1,706 Quality Systems jobs in Singapore

This role supports supplier management programs, including performing quality activities such as supplier qualification, periodic performance monitoring, supplier change notification, decommissioning, establishing quality agreements with suppliers.

Responsibilities:

• Perform supplier qualification activities such as liaising with stakeholders (manufacturing team, procurement team, QC etc.) and suppliers (manufacturers and distributors of supplies, outsourced service provider etc.) to ensure supplier questionnaires are completed with relevant documents (e.g. business license, ISO certificates etc.)
• Liaise with affiliate sites personnel for qualified supplier information deck to assess on the leverage of supplier qualification documents.
• Lead/Support on-site audit at supplier site (if necessary). Prepare audit agenda, audit report and coordinate with supplier for CAPA response to close of audit observations.
• Draft Quality Agreement (QAA) with new suppliers or review existing QAA for existing suppliers engaged by affiliate sites
• Perform quality assessment based on company procedures to determine if suppliers can be qualified for GMP use.
• Update qualified supplier list.
• Perform periodic performance monitoring, supplier change notification and decommissioning of supplier.
• Perform other tasks assigned by leadership.

About You:

• Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.
• At least 8 years of working experience in production and/or quality management, with a minimum of 5 years in supplier qualification QA.
• Familiarity with FDA, EMEA, HSA and PIC/S GMP requirements.
• Experience in leading audits is preferred.
• Experience with biopharma commercial quality systems is preferred.
• Proficient in English listening, speaking, reading, and writing.
• Skilled in Microsoft Word, Excel, PowerPoint, SAP, TrackWise etc.
• Strong learning ability.
• Effective at cross-functional communication and collaboration.

Contract Duration: 6 months

In this pivotal role, you will be responsible for implementing and maintaining our Quality Management System standards and Environment, Health and Safety SOPs and Manuals.

• You will ensure adherence to compliance and regulatory oversight for Standard Operating Procedure, Quality and Safety Manuals, Maintenance Organisation Expositions.
• Liaising with assigned CAA Principal Maintenance Inspector for approvals, certifications, and inspections.
• Conducting Internal Quality Audit, External vendor QMS audits, and managing vendor qualification into the Approved Vendor List.
• Leading audit conducted by Customer.
• Responsible for the Quality and Safety of assigned workshop.
• Investigating incidents and accidents, warranty.
• Supporting the development, review, improvement, and implementation of quality and safety management procedures.

To excel in this position, you will require:

• Diploma in aerospace engineering or equivalent.
• Minimum 3 years of experience in QMS in Aerospace Industry.
• Certified Auditor required.

The ideal candidate will have a strong background in QMS, experience working in a fast-paced environment, and excellent communication skills. Key responsibilities include:

• Maintaining and improving our Quality Management System.
• Ensuring compliance with regulatory requirements.
• Leading audits and investigations.
• Developing and implementing quality and safety procedures.

We are seeking a detail-oriented and proactive professional to support compliance-related administrative functions.

• Documentation review for completeness of work processes is crucial in this role.
• Regular inspections ensure adherence to established procedures, which we continuously monitor and update as needed.
• Comprehensive reports document findings on documentation checks, compliance, and trend updates.
• Follow-up actions are developed and tracked for non-compliant issues, ensuring prompt resolution.
• Effective management of feedback, enquiries, appeals, and disputes supports our goal of providing exceptional service.
• Accurate records of audit activities, findings, recommendations, and follow-ups maintain the integrity of our quality management systems.

For success in this role, applicants should possess:

• Singaporean citizenship or residency.
• Preferred qualifications include WSQ Graduate Certificate in Workplace Safety and Health and relevant ISO auditor certifications.
• A strong understanding of Quality Management Systems, including ISO 9001 principles and other relevant quality standards.

We are looking for a talented Quality Systems Specialist to join our team in Pandan Ave, Singapore. This will be onsite work model.

Acts as an extension of senior management ensuring a positive customer experience while being the representative of senior management to others. Provides administrative support and performs numerous duties, including scheduling, writing correspondence, emailing, overseeing visitors, routing callers and answering questions and requests.

• Anticipates to the needs of senior management and manages his/her schedules. Arranges and coordinates travel arrangements including expense reports and visa/passport requirements.

• Gathers, compiles, verifies and analyses information for management's use in documents such as memos, letters, reports, speeches, presentations and news releases.

• Facilitates smooth communications between senior management and coworkers and between senior management and external parties such as media, customers, vendors and the public. Maintains the security and confidentiality of management's records and files.

• Monitors, reviews and approves standard expenditures to ensure the activities of the office are conducted within established budgets.

• Reports required information on a regular basis as assigned (e.g. monthly).

• Performs various tasks using independent judgement and discretion; e.g., preparing documents and presentation materials; screening and responding to incoming correspondence, inquiries, and phone calls; drafting letters and official information releases; arranging and attending meetings; taking and distributing minutes.

• Act as formal resource for colleagues with less experience.

• Completes other activities for senior management upon request and/or as required.

• Supports the Quality Systems Manager with compliance by ensuring company policies, processes and standards are effectively implemented.

• Leads the planning and completion of ISO 9001 internal audits for the site. Gathers and analyzes data from internal audit findings to make recommendations to leadership team on improving the Quality Management System.

• Engage with Global NRP QA Corp team to lead changes needed for the site. Supports collection and/or calculation of input metrics related to the quality system, scorecards for the Corp.

• Key administrator for CQMS and Document Management System. Supports the key business processes documentation and maintenance, entry of documentation and identifies problems needing addressed, including follow up on overdue approvals, reviews, ownership changes, etc. Helps maintain the quality system documents prescribing the quality management system, the documented procedures or reference to them, and a description of the interactions between the processes of the management system.

• Engages in preparation and analysis for Quality Management reviews (including but not only customer satisfaction), communicates and maintains follow-up actions.

• Provides information as necessary to external auditors or certification bodies, complying with content, timing, and format requirements.

• Delivers/Facilitates specific quality systems related education, e.g., application user training, internal auditor training)

• Responsible for applicable systems related to plant customer issues such as corrective action requests, supplier corrective action requests, nonconforming material reports, etc.

• Conduct of SOX audits and driving corrective actions from our GSCS team for any non-conformities to claims processing found.

• Co-administrator for SMARTLPA system and lead for changes/updates on process audits.

Preferred Qualification:

• High school diploma or certificate of completion of secondary education or equivalent experience to the extent such experience meets applicable regulations.

• This position may require licensing for compliance with export controls or sanctions regulations.

• Significant work experience and in-depth knowledge obtained through specialized training and relevant experience.

This role ensures compliance with ISO 9001:2015 by maintaining and improving the Quality Management System (QMS). Responsibilities include managing QMS document revisions, audits, supporting continual improvement initiatives, conducting quality training, analysing quality data, and addressing nonconformities. The role also oversees KPIs, customer satisfaction, and subcontractor performance, while working closely with all departments to align the QMS with business goals and drive operational excellence.

• Lead and Participate in the company continue improvement program.

• Conduct QMS briefing for new employees and delivery quality-related training programs.

• Develop, implement, and improve the QMS documents, review and improve existing QMS documentation (DCR) for best practices and align with group yards.

• Plan and manage internal and external quality audits, follow up on audit findings till closure.

• Manage the nonconformity process, ensuring timely resolution and corrective actions.

• Prepare Management Review Slides, performing analysis, and preparing meeting minutes. Follow up on improvement suggestions and closure with actionable plans and clear accountability.

• Generate and analyse Quality Monthly report, Identify top quality issues and track closure.

• Manage Departments KPI reporting, follow-up, verification, and analysis.

• Manage Customer Satisfaction reporting and analysis, driving continuous improvement initiatives.

• Oversea in-house calibration records, instruments like micrometres and pressure gauges.

• Conduct subcontractor and supplier qualification audits and monitor their ongoing performance.

• Collaborate with departments to update risks, opportunities, and the needs of interested parties to ensure the QMS remains responsive to business changes.

• Perform any other duties, as assigned by superior.

• ISO 9001:2015 Internal Auditor certificate

• Certified Lean six sigma green belt will be added advantage.

• Degree in Engineering (Marine/Mechanical or related field)

• Experience in continuous improvement activities.

• Experience in conducting quality trainings.

• Experience in creating procedures and work instructions.

• Experience in conducting quality audits.

• Experience in root cause analysis, corrective action processes, and use of various quality tools.

• Experience in data analysis and suggestion for improvement.

This role ensures compliance with ISO 9001:2015 by maintaining and improving the Quality Management System (QMS). Responsibilities include managing QMS document revisions, audits, supporting continual improvement initiatives, conducting quality training, analysing quality data, and addressing nonconformities. The role also oversees KPIs, customer satisfaction, and subcontractor performance, while working closely with all departments to align the QMS with business goals and drive operational excellence.

• Lead and Participate in the company continue improvement program.

• Conduct QMS briefing for new employees and delivery quality-related training programs.

• Develop, implement, and improve the QMS documents, review and improve existing QMS documentation (DCR) for best practices and align with group yards.

• Plan and manage internal and external quality audits, follow up on audit findings till closure.

• Manage the nonconformity process, ensuring timely resolution and corrective actions.

• Prepare Management Review Slides, performing analysis, and preparing meeting minutes. Follow up on improvement suggestions and closure with actionable plans and clear accountability.

• Generate and analyse Quality Monthly report, Identify top quality issues and track closure.

• Manage Departments KPI reporting, follow-up, verification, and analysis.

• Manage Customer Satisfaction reporting and analysis, driving continuous improvement initiatives.

• Oversea in-house calibration records, instruments like micrometres and pressure gauges.

• Conduct subcontractor and supplier qualification audits and monitor their ongoing performance.

• Collaborate with departments to update risks, opportunities, and the needs of interested parties to ensure the QMS remains responsive to business changes.

• Perform any other duties, as assigned by superior.

• ISO 9001:2015 Internal Auditor certificate

• Certified Lean six sigma green belt will be added advantage.

• Degree in Engineering (Marine/Mechanical or related field)

• Experience in continuous improvement activities.

• Experience in conducting quality trainings.

• Experience in creating procedures and work instructions.

• Experience in conducting quality audits.

• Experience in root cause analysis, corrective action processes, and use of various quality tools.

• Experience in data analysis and suggestion for improvement.

Company Overview:

Are you ready to see your career take flight? At GE Aerospace, we believe the world works better when it flies. We are a world-leading provider of jet engines, components, and integrated systems for commercial and military aircraft. We have a relentless dedication to the future of safe and more sustainable flight and believe in our talented people to make it happen.

Site Overview:

For more than 40 years, our advanced facilities in Singapore have led aerospace innovation across Asia Pacific. From automating processes to leveraging smart factory technologies, robotics, and additive manufacturing, GE Aerospace is shaping the future of aviation at GE Aerospace Engine Services Singapore (GEAESS).

GEAESS is our largest site for engine component Maintenance, Repair, and Overhaul (MRO), responsible for more than 60% of our global repair volume.

Role Overview:

• Design, maintain and administer GEAESS' Quality System.

• Support and administer GEAESS’ Safety Management System

• Administer the internal quality audit programs - process, work station, final product, quality systems, source substantiation processes and package audits.

• Be in control of GEAESS’ Document Control Center. Assure all data and records are up-to-date and that revisions, if any, are distributed to all Process and Product Engineers affected.

• As a first priority, act to prevent the release of shipment of any non-conforming material from GEASS.

• Facilitate all regulatory and customer audits, work with the appropriate functions in the formulation of corrective actions.

• Initiating, updating and maintaining QCWls and other Quality documents as and when required.

Ideal Candidate

• The ideal candidate is a detail-oriented and proactive professional with a degree in engineering and at least 3 years of relevant experience in quality systems and aircraft component repair. They possess strong leadership, auditing, and organizational skills, along with knowledge of ISO/Part 145 regulations and CAAS Air Legislation, enabling them to effectively manage quality systems and safety programs in a fast-paced aerospace environment.

Required Qualifications

• Degree (Engineering) or equivalent with 3 years of relevant experience

• Knowledge of basic engineering & aircraft component repair

• Auditing experience

• Knowledge of Quality Systems/1S0/Part 145 regulation

• Leadership/facilitation/supervisory skill

• CAAS Air Legislation Paper

• Basic knowledge of PC software & good communication skills

Preferred Qualifications

• Able to multi-task effectively and manage multiple priorities at one time.

• Able to work effectively with minimum supervision.

• Strong interpersonal and leadership skills.

• Strong organizational and project management skills.

At GE Aerospace, we have a relentless dedication to the future of safe and more sustainable flight and believe in our talented people to make it happen. Here, you will have the opportunity to work on really cool things with really smart and collaborative people. Together, we will mobilize a new era of growth in aerospace and defense. Where others stop, we accelerate.

Relocation Assistance Provided: No

Overview

Assoc Specialist, Quality Systems — Role Purpose: Perform quality operations as per transition service agreement to maintain compliance of regional regulatory requirements.

• Warehouse Quality Management: Implement and maintain Product Inspection Process and Product Release Process, including Imported Finished Goods, and Returned Products; maintain compliance of country specific labeling process; implement and track Quality Hold (Global & local) in 3PL; drive improvement for 3PL Quality Management System, implement and maintain Quality Agreements; drive and execute rework activities; initiate and track internal complaints resulting from labeling and other regulatory non-compliance; perform first article inspection (FAI) for product distributed in Asia Pacific & greater China region; ensure implementation of company’s procedure/work instruction in warehouse; manage and follow up SCARs.
• Act as quality engineer for Asia Pacific labeling and other quality documentation.
• Supplier quality: maintain existing supplier and support in new supplier qualification; provide Quality Training to suppliers.
• Post Market Quality Assurance: oversight and maintain compliance of Product Complaint Handling Process in APAC (including receiving and reporting complaints to CH Center, following up complaint investigation, sample return, etc.).
• Execute Field Corrective Action Process including operations in JDE system. Act as Local FCA Coordinator for Region.
• Generate quality system reports and perform trend analysis.
• Maintain training compliance for region.
• Participate on audit teams by responding and gathering data to address audit requests.
• Own and manage NCR, CAPA, PRA in region.
• Assess the impact of quality systems information (e.g., Enterprise Change Requests (ECRs), CAPA) and provide feedback to originators.
• Other incidental duties.

• Bachelor’s degree in related field
• 3 years of previous experience in quality and/or manufacturing environment in the medical device industry

• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving and critical thinking skills
• Good knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality systems
• Good knowledge of medical or pharmaceutical regulations as relating to documentation
• Good understanding of medical devices regulations (e.g. ISO13485)
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Must be able to work in a team environment, including immediate supervisor and other team members in the section or group
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

• Mid-Senior level

• Contract

• Health Care Provider and Manufacturing

• Medical Equipment Manufacturing
• Pharmaceutical Manufacturing

We are looking for a talented Quality Systems Specialist to join our team in Pandan Ave, Singapore. This will be following Onsite work model.

• Anticipates the needs of senior management and manages their schedules. Arranges and coordinates travel arrangements including expense reports and visa/passport requirements.
• Gathers, compiles, verifies and analyses information for management's use in documents such as memos, letters, reports, speeches, presentations and news releases.
• Facilitates smooth communications between senior management and coworkers and between senior management and external parties such as media, customers, vendors and the public. Maintains the security and confidentiality of management records and files.
• Monitors, reviews and approves standard expenditures to ensure the activities of the office are conducted within established budgets.
• Reports required information on a regular basis as assigned (e.g., monthly).
• Performs various tasks using independent judgement and discretion; e.g., preparing documents and presentation materials; screening and responding to incoming correspondence, inquiries, and phone calls; drafting letters and official information releases; arranging and attending meetings; taking and distributing minutes.
• Acts as a formal resource for colleagues with less experience.
• Completes other activities for senior management upon request and/or as required.

• Values differences – Recognizing the value that different perspectives and cultures bring to an organization.
• Action oriented – Taking on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm.
• Communicates effectively – Developing and delivering multi-mode communications that convey a clear understanding of the unique needs of different audiences.
• Customer focus – Building strong customer relationships and delivering customer-centric solutions.
• Ensures accountability – Holding self and others accountable to meet commitments.
• Plans and aligns – Planning and prioritizing work to meet commitments aligned with organizational goals.
• Data Analytics – Discovers, interprets and analyses qualitative and quantitative data; applies statistics, data validity, data visualization, and problem-solving approaches to extract meaningful patterns and business insights; presents conclusions that enable data-driven decisions.
• Data Communication and Visualization – Constructs a narrative of the business problem, root cause, solution options, and opportunities through data visualization, reports and dashboards.

• High school diploma or equivalent; relevant experience may meet regulatory requirements.
• This position may require licensing for compliance with export controls or sanctions regulations.
• Significant work experience and in-depth knowledge obtained through specialized training and relevant experience.
• Supports the Quality Systems Manager with compliance by ensuring company policies, processes and standards are effectively implemented.
• Leads the planning and completion of ISO 9001 internal audits for the site. Gathers and analyzes data from internal audit findings to improve the Quality Management System.
• Engages with Global NRP QA Corp team to lead changes needed for the site. Supports collection and analysis of input metrics related to the quality system and scorecards for the Corp.
• Administrates CQMS and Document Management System; supports documentation maintenance, tracking approvals, and ensuring documentation reflects the quality management system.
• Supports Quality Management reviews (including customer satisfaction) and follows up on actions.
• Provides information to external auditors or certification bodies as required.
• Delivers quality systems related education, e.g., user training and internal auditor training.
• Responsible for systems related to plant customer issues such as corrective actions and nonconforming material.
• Supports SOX audits and drives corrective actions for non-conformities to claims processing.
• Co-administrator for SMARTLPA system and leads process audit updates.

Job Quality

Organization Cummins Inc.

Role Category Remote

Job Type Office

ReqID

Relocation Package No