Quality Engineer Senior

The Quality Engineer Sr will be responsible for ensuring the highest standards of quality throughout our organization and provide strategic thinking with a deep understanding of quality management systems, change control requirements & processes, and a proven track record of implementing and maintaining robust quality processes.

• Lead and support quality engineering activities for manufacturing processes, including process validation, equipment qualification (IQ/OQ/PQ), and change management.
• Lead root cause investigations and corrective and preventive action (CAPA) using structured problem-solving methodologies.
• Lead and support nonconformance handling, deviations, disposition, and approval of nonconforming product.
• Support site leadership during internal and external audits and inspections; act as a subject matter expert during FDA, notified body, and supplier inspections.
• Analyze quality metrics and trends; drive continuous improvement initiatives using Lean, Six Sigma, or similar methodologies.

• Provide mentorship and technical guidance to junior quality engineers and quality inspectors. 

• Collaborate cross-functionally with Manufacturing, R&D, Supply Chain, Regulatory Affairs, and other groups to ensure product quality and compliance throughout the product lifecycle.
• Lead reportable complaint investigations and coordinate activities with other stakeholders (DQA, PMS, etc.).
• Where necessary, support supplier quality activities, including supplier qualification, performance monitoring, and issue resolution.
• Serve as quality representative on cross-functional teams for new product introduction (NPI), design transfer, and manufacturing scale-up.
• Participate in other projects as required by quality management.

• Perform other duties as assigned.

• In-depth knowledge of 21 CFR 820, ISO 13485, EU MDR, MDSAP, and other global standards.
• Ability to work in a matrixed organization, developing strong relationships with all levels of staff and management, partnering across multidisciplinary teams (internal/external).
• Hands-on experience with process validation, CAPA, nonconformance management, and change control.
• Strong time management skills to drive multiple projects to completion on time.
• Strong organizational, interpersonal, verbal, and written communication skills (clear, concise, effective with a variety of stakeholders).
• Strong data analysis, negotiation, and problem-solving skills.
• Must be proficient in the use of Microsoft Excel, Microsoft Word, Outlook, and PowerPoint.
• Experience in participating in regulatory audits/inspections is required.

• Proficient in reading, writing, and communicating in the English language.