Quality Engineer (Device/Diagnostics Manufacturing) – RTP/High Growth
Our client, an RTP area medical device company in high growth mode, is actively recruiting for a very sharp and can-do candidate to assume a key role on its Quality team.
This is one of the fastest-growing companies in the Triangle. It manufactures point-of-care diagnostic tools that aid in the management of critical bleeding and clotting. They manufacture both the analyzing equipment as well as disposable cartridges. This Quality Engineer will be responsible for ensuring the quality of both, including pre-production and post-market efforts.
Things to Note:
- This challenging and diverse role will involve review of Device History records, incoming component testing, material specification and drawings, investigations, post-market surveillance, etc. Experience with batch record approval, material inspections and extensive knowledge of good Quality practices will be essential.
- The company relies on third party vendors for the production of certain products and parts. Seek candidate with substantial experience in supplier audits.
- This role will involve extensive contact with site staff, vendors, colleagues, etc. Right candidate will complement Quality Engineering strength and knowledge with polished, constructive and diplomatic communication skill.
- As an emerging business, policies and practices are still being developed and enhanced. Successful candidate will bring ingenuity, flexibility and drive.
- Review and approve quality records for component and finished medical device release
- Review incoming inspection records to ensure the quality of assigned components for release to production
- Utilize statistical analysis techniques to determine product acceptance and AQL sampling plans, evaluate process capabilities, and develop statistically sound tolerance limits
- Review Device History records to ensure the quality of assigned products for review for sale
- Track and report quality metrics for Management Reviews
- Contribute to Deviation process, non-conformance reporting system, and root-cause investigations
- Identify non-conformance trends and develop and administer technical investigation and CAPA programs to resolve recurring quality problems
- Update procedures to ensure Quality System is compliant with ISO standards, FDA regulations and adherent to HIPAA
- Lead and/or support internal and external supplier audits and inspections.
- Ensure Quality Management System and project documentation are maintained to ensure retrieval for audits.
- Support the Complaint Handling Unit by investigating, determining root cause and ultimate resolution of product failures.
Targeted candidate will offer a technical BA/BS degree and 3+ years’ experience as a Quality Engineer in the diagnostics or medical device industry. Client may consider Quality Engineers from pharma mftg as well.
Other priorities include:
- Experience participating in internal and external audits in an FDA regulated setting
- Experience with batch record review (DHR), incoming inspections, CAPA, non-conforming product investigations, deviations, change control, training and document control, complaint investigation, field action processes and risk management
- Ability to review, analyze, summarize, and interpret data for Management Reviews
- Knowledge of validation, statistical process controls, and regulatory compliance. Statistical analysis skills
- Ability to formulate appropriate responses to common Quality inquiries
- Certified Quality Engineer and/or Certified Quality Auditor preferred
Finally, we seek a hands-on. get things done candidate who will work exceedingly well in this dynamic, empowered setting. A lot is happening. We seek a skilled and driven achiever who will thrive.
This is a Direct Hire opportunity. Compensation will be generous and include base, bonus and benefits. Please forward Word resume for prompt consideration.
Local candidates only.