Job Description
Manpower Engineering is partnering with a leading specialty medical-device company that combines their drug development expertise, proprietary delivery technology, and innovative device design to provide safe and effective medicinal treatments to patients across the globe.
Position Summary:
The Principal Quality Engineer II leads quality engineering activities for commercial products, including process validation, maintenance of DMR and risk management files, complaint risk analysis, and CAPA/SCAR/Deviation investigations. This position also participates in quality engineering activities for commercial scale up prior to product launch and supports internal and contract manufacturing. Through these activities, the Principal Quality Engineer II will verify quality, reliability, and compliance of mechanical product designs.
Key Responsibilities:
* Drive product quality and compliance while adhering to medical device and FDA standards and regulations.
* Support contract manufacturing activities including Process Development, Process Validation, Change Control and Nonconformance resolution.
* Lead CAPA, Nonconformance and Supplier CAPA investigations and author corresponding reports in alignment with industry standard methodologies.
* Train and mentor quality, multi-functional partner and CMO team members on quality processes and procedures.
* Represent the company in quality-related meetings and discussions with customers and suppliers.
* Support DMR content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps.
* Maintain release testing plans and associated test methods and procedures.
* Maintain risk management files for commercial products via periodic review of risk documents, complaints and nonconformance trends.
* Build and manage relationships with key CMO's and partners to facilitate continued supply of high-quality commercial products.
Qualifications:
* BS degree in Engineering (Mechanical, Material Sciences or Biomedical) or related field.
* Minimum of 10 years' experience in quality engineering within the medical device industry.
* Knowledge of GMP, ISO, QSR and other applicable international medical regulations, standards, directives and guidance for Class II Devices and/or drug/device combination Products.
* Strong collaboration and leadership skills with the ability to work cross functionally and between customer and supplier organizations.
* Strong technical skills related to product quality including process Verification/ Validation, Test Method Validation, Process Validation, Inspection Techniques, Root Cause Investigation, and Statistics.
* Experience working with Contract Manufacturers and with Customers, including communication of complex technical concepts and investigations, and resolution of quality issues.
* Lead auditor certification preferred.
* Six Sigma Belt preferred.
What's in it for YOU?
* Competitive Base Salary
* 13% Annual Bonus
* Generous Stock Options
* 401K Match - 100% Vested on Day 1
* Hybrid Schedule - 3 days/wk remote & 2 days/wk onsite
* 5 Weeks of PTO
* Flexible Schedule/Hours
* $5K Annual Tuition Reimbursement
* Excellent Opportunities for Career Growth
* Collaborative and Positive Work Environment