Sr. Quality Engineer

Position Summary:

The Senior Quality Engineer is a key contributor to the quality assurance team, responsible for leading quality initiatives across product development, manufacturing, and supplier management. This role ensures compliance with regulatory standards and drives continuous improvement in quality systems, processes, and product performance. The ideal candidate will have deep expertise in medical device regulations and a proactive approach to problem-solving and cross-functional collaboration.

Key Responsibilities:

• Lead quality engineering activities for new product development, including design control, risk management, and validation (IQ/OQ/PQ).
• Support manufacturing operations by resolving quality issues, implementing process improvements, and ensuring compliance with GMP.
• Conduct root cause analysis and lead corrective and preventive actions (CAPA).
• Develop and maintain quality documentation, including procedures, work instructions, and validation protocols.
• Participate in internal and external audits (FDA, ISO, Notified Bodies) and support regulatory submissions.
• Collaborate with R&D, Manufacturing, and Regulatory Affairs to ensure product quality throughout the lifecycle.
• Analyze quality data and trends to identify opportunities for improvement and report findings to leadership.
• Mentor junior engineers and support training initiatives across the organization.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and other applicable standards.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related field (Master's preferred).
• 5+ years of experience in quality engineering within the medical device industry.
• Strong knowledge of design controls, risk management, validation, and regulatory compliance.
• Experience with CAPA, root cause analysis, and statistical tools (e.g., Minitab, JMP).
• Familiarity with QMS software and document control systems.
• ASQ CQE, Six Sigma, or similar certification is a plus.
• Excellent communication, analytical, and project management skills.

Preferred Skills:

• Experience with Class II or Class III medical devices.
• Knowledge of sterilization, packaging validation, and biocompatibility testing.
• Ability to work independently and lead cross-functional teams.