Principal Quality Engineer

Position Summary

The Principal Quality Engineer will lead cross-functional project teams and contribute to product specification development and quality planning activities. Responsibilities include authoring and managing documentation for design verification and validation, software and process validations, human factors, and risk analysis. Lead the analysis of complaint data and develop metrics and ensure compliance with quality management systems and regulatory requirements are key tasks. Supporting production by troubleshooting issues and improving yields, collaborating with contract manufacturers to resolve issues, closing non-conforming material reports promptly, and ensuring adherence to internal procedures are crucial. Additionally, assisting in conducting supplier audits, maintaining up-to-date technical knowledge, and supervising and mentoring production inspectors are important duties. 

Job Responsibilities

• Responsible for quality engineering review of Document Change Orders for Product Development and Software update. 
• Act as the Subject Matter Expert for QA for Design Control SOPs, DHF, Standards Compliance, and Design Transfer records. Support regulatory audits of Product Development function and outputs. 
• Review, approve, and provide guidance for Design Verification and Validation activities, product and software traceability matrix. 
• Perform firmware/software verification, regression, and integration testing: including testing software fixes, cybersecurity update and logging/tracking software defects. 
• Create and design appropriate test methods, protocols and accurately generate complex written reports which include establishing statistical confidence by identifying sample size and acceptable error rates. This includes testing for process validations, test method validation and data analysis.
• Lead the development of complaint metrics to ensure appropriate measurement of product performance.
• Lead CAPA generation, performing thorough root cause investigation and documenting corrective and preventative action plans. Ensure action plans are implemented in a timely manner.
• Evaluate significant product and/or process changes and enhancements which reduce defects, improve yields, and lower product cost. Proactively solve moderately complex problems at the product level.
• Assist with risk analysis activities and maintaining up to date risk management documents.
• Support company goals and objectives, policies and procedures, Quality System Regulation, and FDA/EU MDR regulations. Adhere to established company Quality System procedures, the Quality Policy, and work instructions.

Other Duties and Responsibilities 

• Partner with the Regulatory Affairs staff to ensure technical accuracy for domestic and international regulatory filings.
• Maintain a professional, credible image with key physicians, consultants, suppliers, and co-workers.
• Other duties as assigned.  

Education & Experience:

• BS in biomedical engineering, or equivalent
• Minimum seven (7) years of experience is preferred, with related medical device experience.
• Understanding of regulatory requirements for the medical device industry, specifically 21 CFR 820, ISO 13485, ISO 14971, 21 CFR 11 and EU MDR. 

Knowledge, Skills, & Abilities:

• Proficiency with PC-based office computers, including familiarity with Microsoft Office suite required. Proficiency with statistical software, such as MiniTab, preferred.
• Ability to work independently, using good judgment, initiative and analytical abilities, to accomplish short and long-range projects, anticipate likely needs, and recommend actions with minimal direction.
• Ability to work as a team member and ability to be very flexible, adaptable, and to work under pressure.
• Self-motivated and self-directed; conscientious approach to work assignments; enjoys the challenges of multitasking and working at a fast pace while staying flexible to shift tasks frequently.
• Must be available and willing to work flexible schedules, as needed.
• Ability to clearly write engineering justifications and analyses connecting product performance with compliance requirements.
• Required to stand, walk and sit; talk or hear; use hands to finger, handle or feel objects or controls; reach with hands and arms.
• Required to stoop, kneel, bend, crouch and lift up to 20 pounds. 
• Specific vision abilities required by this job include close vision, distance vision, depth perception, color vision and the ability to adjust focus.
• Subject to extended periods of sitting and/or standing, vision to monitor, and moderate noise levels. 

Salary Ran