quality manager
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard Office Hours (40/wk)Environmental Conditions
OfficeJob Description
Quality Manager - Manufacturing
At Thermo Fisher Scientific Inc. we are in search of a diligent Quality Manager to supervise our quality control activities in the manufacturing of medical devices. This opportunity provides an outstanding prospect to be part of a driven team that aims for flawless implementation and industry-leading benchmarks in all operations. Join us in our commitment to promoting a healthier cleaner and safer world!
Key Responsibilities:
- Quality System Management:
Develop and maintain a robust quality system to ensure regulatory compliance and continuous improvement.
1. Coordinate documentation management to ensure the efficiency of the quality system.
Conduct regulatory intelligence to monitor and act on relevant laws and standards.
- Quality Assurance:
Manage quality control functions and operational permissions of computer information systems.
1. Review and dynamically manage the qualifications of medical device suppliers products and purchasers.
Confirm and supervise the handling of non-conforming medical devices.
1. Coordinate the verification and calibration of relevant facilities and equipment.
Implement UDI to ensure medical device traceability.
- Post-Market Surveillance:
Investigate handle and report medical device quality complaints and incidents.
1. Manage medical device recalls and quality safety risk consultations.
Collect and report adverse events related to medical devices.
Qualifications:
- Bachelors degree in medical device life science chemistry or a closely related field.
- Over 5 years of professional experience in quality management within the medical device industry.
- In-depth knowledge of GSP ISO 13485 regulations.
- Proficient in English (both oral and written).
- Demonstrated ability to manage people with strong interpersonal skills for collaborating across teams and working with interested parties.
Join us on this outstanding journey and contribute to our mission of delivering world-class quality in medical device manufacturing. Apply your skills and experience to help us achieve flawless execution and compliance!
Required Experience:
Manager
Key Skills
- APQP
- Quality Assurance
- ISO 9001
- Lean Six Sigma
- PPAP
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Control
- Quality Management
- As9100
- Manufacturing
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
