Senior Manufacturing Quality Engineer

Key Responsibilities

• Serve as the primary Quality partner for manufacturing, helping teams execute compliant, practical processes within the QMS.
• Partner with Manufacturing and Engineering to define, qualify, and improve production processes, including process mapping, critical parameter identification, and control strategy development.
• Support disciplined issue resolution by identifying root causes, implementing corrective actions, and reducing recurring manufacturing variability.
• Plan and execute IQ/OQ/PQ activities for cleanroom equipment and manufacturing processes, ensuring documentation is audit-ready and aligned with regulatory expectations.
• Establish process monitoring and control methods, including SPC, yield tracking, process capability metrics, and appropriate metrology or measurement-system analysis.
• Absess equipment capability, stability, preventive maintenance needs, and quality controls required for reliable production.
• Develop and review manufacturing documentation, including work instructions, job travelers, SOPs, test methods, inspection criteria, and sampling plans.
• Support incoming, in-process, and final inspection strategies, material traceability, disposition processes, and inventory-related quality controls.
• Contribute to MRP/ERP workflows that support traceability, QMS requirements, training, and audit readiness.
• Partner with R&D, Manufacturing, Operations, and Quality to translate development processes into controlled, repeatable production practices.
• Coach engineers and operators on working effectively within a regulated QMS and maintaining strong documentation habits.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Chemical, or related field) or equivalent technical discipline.
• 5–7 years of experience in manufacturing quality or quality engineering within the medical device industry.
• Strong experience working within FDA-regulated and ISO 13485-compliant QMS environments.
• Hands-on experience supporting process validation, equipment qualification, process controls, and manufacturing documentation.
• Experience with cleanroom manufacturing, semiconductor, MEMS, nanofabrication, or other complex precision manufacturing environments is preferred.
• Experience supporting design transfer, manufacturing scale-up, MRP/ERP implementation, or startup environments is a plus.

Skills

• Solid understanding of medical device regulations, including 21 CFR Part 820 and ISO 13485.
• Strong working knowledge of validation, process control, inspection methods, SPC, DOE, and root-cause analysis tools.
• Ability to translate regulatory requirements into practical, scalable manufacturing processes.
• Strong project management, communication, and cross-functional collaboration skills.
• Hands-on, detail-oriented approach with the ability to balance rigor, prioritization, and speed in a growing organization.

What We Offer

• An opportunity to work with a team of experts on one of the most exciting problems in the world and change lives.
• Career growth opportunities that fit your potential.
• Comprehensive benefits plan including health and dental insurance; parental leave.
• Flexible paid time off.