Quality Engineer II
Quality Engineer II
Posted on :
12-06-2025
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1 Vacancy
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Job Description
Responsibilities:
- Facilitating business data collection reporting efforts and generating periodic product PSUR / post market surveillance reports.
- Use local and global systems to collect various post market information such as complaint field corrective action and CAPA data.
- Work with subject matter experts to analysed product related data and document conclusions of the review activities.
- Analysis of post market data and reviewing completed reports with business partners.
- Maintaining and supporting databases and systems used for tracking various quality management system (QMS) activities related to post market surveillance.
- Maintain archive and completed controlled quality records.
- Coordinate PMS and post market performance follow-up (PMPF) deliverables with internal business partners.
- Facilitate and/or chair local/regional PMS Board meetings.
- Support various QMS and PMS projects (local and global) as needed.
- Support internal/external audits as needed.
- Perform other related duties and assignments as needed.
- Bachelors degree or equivalent in a related life science/technical/engineering discipline or equivalent preferred.
- 5 years of experience in a regulated manufacturing industry or equivalent combination of education and experience.
- Understanding of GMP and quality system standards.
- Facilitation and generation of product Post Market Surveillance (PMS) and PSUR reports.
- Analysis of post market data understanding of product post market surveillance requirements for IVD products a plus.
- Working knowledge of device/drug/biotech manufacturing processes.
- Advanced technical writing and word processing skills.
- Experience with electronic systems (i.e. Veeva etc. Track Wise).
Employment Type
Full Time
Key Skills
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