Regulatory Affairs Associate
3 weeks ago
Quality Engineer II
Location: Hercules, CA. (Hybrid)
7 month assignment (Great potential to extend)
Pay Rate: $45-$49/hr. doe
On behalf of our client a leading manufacturing medical device company. We are seeking for a candidate that will be a part of the global PSUR Reporting Team. Candidate will be facilitating business data collection, reporting efforts and generating periodic product PSUR / post market surveillance reports. This includes regular interactions with area subject matter experts to ensure data is collected, documented, and analyzed.
Job Responsibilities:
- Facilitation and generation of product Post Market Surveillance (PMS) and PSUR reports.
- Use local and global systems to collect various post market information such as complaint, field corrective action and CAPA data.
- 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.
Education and Experience:
- Bachelor’s degree or equivalent in a related life science/technical/engineering discipline or equivalent preferred.
- 5+ years’ experience in a regulated manufacturing industry or equivalent combination of education and experience.
- Understanding of GMP and quality system standards.
- Understanding of product post market surveillance requirements for IVD products a plus.
- Working knowledge of device/drug/biotech manufacturing processes.
- Experience with electronic QMS systems (i.e. Veeva, EtQ, Trackwise) a plus.
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