Quality Management System Specialist

1 month ago


Singapur, Singapore Thermo Fisher Scientific Full time
Job Title: QMS Engineer

At Thermo Fisher Scientific, we are seeking a highly skilled QMS Engineer to join our team. As a QMS Engineer, you will play a critical role in ensuring the quality and compliance of our medical devices.

Key Responsibilities:
  • Develop, implement, and maintain the Quality Management System (QMS) in compliance with relevant regulatory standards, including FDA and ISO 13485.
  • Conduct internal audits and assessments to ensure compliance with quality standards and identify areas for improvement.
  • Collaborate with multi-functional teams to maintain quality objectives, key performance indicators, and metrics.
  • Track and analyze quality data to identify trends, issues, and opportunities for process improvement.
  • Facilitate and participate in management reviews to drive continuous improvement efforts.
  • Handle regulatory or customer inspections and audits, as necessary.
  • Assist in the development and delivery of training programs related to the QMS.
  • Lead document periodic review and coordinate with internal parties to maintain and update all necessary documentation to align with system requirements.
  • Establish site policies and procedures in maintaining the QMS.
  • Identify and implement process improvement opportunities, cost improvement, and monitor the efficiency.
Qualifications:
  • Bachelor's degree in engineering or a related field.
  • Solid understanding and experience with relevant quality standards and regulations, including FDA QSR and ISO 13485.
  • Previous experience working in the medical device industry and familiarity with QMS requirements specific to this industry.
  • Proficiency in conducting internal audits and assessments.
  • Certified ISO13485:2016 internal auditor is preferred.
Experience:
  • A minimum of 3-5 years' proven experience in medical device (IVD) manufacturing environment.
  • Experience in a regulated industry preferred.
Competencies:
  • Capacity to work both independently and in a team-orientated environment.
  • Strong and effective communication and interpersonal skills to collaborate with multi-functional teams.
  • Strong attention to detail and ability to work with complex documentation.
  • Excellent analytical and problem-solving skills.


  • Singapur, Singapore HKM HR MANAGEMENT PTE. LTD. Full time

    Job SummaryHKM HR MANAGEMENT PTE. LTD. is seeking a skilled Quality Assurance Specialist to join our team. As a key member of our quality control department, you will be responsible for ensuring the highest standards of quality in our manufacturing processes.Key ResponsibilitiesCollaborate with the Process Engineer and Engineering team to establish and...


  • Singapur, Singapore Crédit Agricole CIB Full time

    Job Title: Quality Assurance SpecialistJob Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at Crédit Agricole CIB. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our payment systems and core banking applications.Main Responsibilities:Develop and execute test plans to ensure the...


  • Singapur, Singapore ST Engineering Full time

    Job Title: Quality Assurance SpecialistAt ST Engineering, we are seeking a Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring the quality of our manufacturing processes and products.Key Responsibilities:Apply organizational quality systems in manufacturing processes.Interpret technical drawings and...


  • Singapur, Singapore 825 Glaxo Wellcome Manufacturing Pte Ltd Full time

    To lead, support and maintain effective and compliant quality systems relating to: Change Control System Quality Management System (QMS) Quality Alerts and Quality Bulletins Deviation Management System Corrective Action and Preventive Action (CAPA) System Product Quality Review (PQR) General For each assigned Quality System(s) : Lead...

  • Quality Specialist

    23 hours ago


    Singapur, Singapore Reinhausen Singapore Pte. Ltd. Full time

    For our location Singapore we are looking for you as: Quality Specialist What challenges can you expect? Perform inspection support including first process, in process and final outgoing inspection. Understand in-depth of each customer’s order and recording all knowledge-based information into company shared drive for future references....


  • Singapur, Singapore ST Engineering Full time

    Job Title: Quality Assurance SpecialistJob ID: ST EngineeringJob Summary:We are seeking a Quality Assurance Specialist to join our Advanced Manufacturing Design Centre (AMDC) team. The successful candidate will be responsible for leading the quality assurance aspect of AMDC, supporting our quality management system and quality plan, and ensuring the...


  • Singapur, Singapore Pfizer Full time

    Job Title: QA SpecialistJob SummaryPfizer is seeking a highly skilled QA Specialist to join our quality assurance team. As a QA Specialist, you will be responsible for ensuring the quality and compliance of our pharmaceutical products.Key ResponsibilitiesReview and approve master batch records and subsequent batch records associated with the manufacturing,...


  • Singapur, Singapore Talent Trader Group Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance and Control Specialist to join our team at Talent Trader Group. As a Quality Assurance and Control Specialist, you will be responsible for developing and implementing quality control processes and procedures for trackwork and railway projects.Key ResponsibilitiesDevelop and implement quality...


  • Singapur, Singapore Baxter Full time

    Transforming Healthcare through Quality ExcellenceBaxter is a leading global medical technology company that has been pioneering significant medical innovations for over 85 years. We are deeply connected by our mission to save and sustain lives, and we are committed to creating a workplace where our employees can thrive and make a positive impact on people's...

  • Quality Specialist

    6 months ago


    Singapur, Singapore Baxter Full time

    This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...


  • Singapur, Singapore airbus Full time

    Job Title: Quality Assurance SpecialistJoin Satair Pte Ltd as a Quality Assurance Specialist and contribute to the success of our company by ensuring the highest quality standards in our aircraft maintenance and quality assurance processes.Job Responsibilities:Implement and manage an independent quality and safety system to ensure compliance with relevant...


  • Singapur, Singapore Kemin Industries Full time

    Job SummaryKemin Industries is seeking a highly skilled Quality Assurance Specialist to join our dedicated and highly effective Quality QA/QC team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and safety of our ingredients and products.Key ResponsibilitiesDevelop and implement quality control and quality management...


  • Singapur, Singapore Baxter Full time

    Transforming Healthcare through Quality ExcellenceBaxter is a leading medical device company that is deeply committed to improving patient outcomes. We are seeking a highly skilled Quality Assurance Senior Specialist to join our team in Singapore.As a Quality Assurance Senior Specialist, you will play a critical role in ensuring the development,...


  • Singapur, Singapore Activate Interactive Pte Ltd Full time

    Quality Assurance SpecialistWe are seeking a skilled Quality Assurance Specialist to join our team at Activate Interactive Pte Ltd. As a Quality Assurance Specialist, you will be responsible for developing and implementing test strategies and test plans, designing test cases and executing tests, and developing and maintaining test automation frameworks and...


  • Singapur, Singapore Parkway Pantai Limited Full time

    The RoleWe are seeking a highly motivated and experienced Quality Management Specialist to join our team at Parkway Pantai Limited. The successful candidate will be responsible for planning, implementing, and reviewing the effectiveness of Quality Improvement courses.Key ResponsibilitiesDevelop and implement a Quality-related training plan for SOD, including...


  • Singapur, Singapore RECRUIT EXPERT PTE. LTD. Full time

    Key Responsibilities:As a Quality Assurance Specialist at RECRUIT EXPERT PTE. LTD., you will work closely with the project team to assist the Quality and Validation Manager Asia region in completing tasks on schedule and within quality standard compliance. Your responsibilities will include the completion of quality, cost, and time validation functions for...


  • Singapur, Singapore Flintex Consulting Pte Ltd Full time

    Job Title: Healthcare Quality SpecialistFlintex Consulting Pte Ltd is seeking a highly skilled Healthcare Quality Specialist to join our team. As a key member of our quality management team, you will play a critical role in driving compliance and quality programs for our healthcare transportation and facilities.Key Responsibilities:Determine, implement, and...


  • Singapur, Singapore U3 Full time

    Job OverviewAt U3, we are seeking a skilled Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest quality of our software products.Key Responsibilities:Perform performance testing, automation, and mobile testing to identify and report defects.Collaborate with...


  • Singapur, Singapore Flintex Consulting Pte Ltd Full time

    Job Summary:We are seeking a highly skilled and motivated Electrical Systems Specialist to join our team at Flintex Consulting Pte Ltd. As an Electrical Systems Specialist, you will be responsible for setting up and commissioning various electrical systems, conducting thorough testing and maintenance, and providing exceptional support to our clients.Key...


  • Singapur, Singapore ResMed Full time

    Job Summary:The Quality Assurance, Quality Systems function is responsible for ensuring that management systems are established to enable business compliance, multiple regulatory frameworks, and to support the design, development, and manufacture of products that meet customer quality requirements.Key Responsibilities:* Support the preparation and...