Manager - Quality Engineering

Job Summary:
We are seeking an experienced and strategic Manager of Quality Engineering to lead a team of quality professionals supporting product development, manufacturing, and regulatory compliance. This individual will play a key role in ensuring product quality and process integrity throughout the lifecycle.

Key Responsibilities:

• Lead and mentor a team of quality engineers focused on product design, manufacturing, and quality system support.

• Oversee the application of quality engineering principles, including risk management, process validation, and design controls.

• Ensure compliance with applicable regulatory and quality standards, such as FDA QSR, ISO 13485, and EU MDR.

• Collaborate cross-functionally with R&D, operations, regulatory, and manufacturing teams to drive quality initiatives.

• Manage quality engineering activities for CAPA, nonconformances, complaints, and continuous improvement.

• Support internal and external audits, and contribute to regulatory submissions.

• Provide input into long-term quality strategy, resource planning, and system improvements.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline (advanced degree preferred).

• Minimum of 7 years of experience in the medical device industry, with at least 2 years in a leadership capacity.

• Strong knowledge of quality engineering practices, product lifecycle management, and risk-based decision-making.

• Experience with Class II or III medical devices is highly desirable.

• Excellent leadership, problem-solving, and communication skills.