Senior Quality Engineer

A growing medical device manufacturer is seeking a Senior Quality Engineer to support the production of a specialized, patient-safety-focused product line. This is a newly created role driven by company growth, reporting directly to the Director of Quality Assurance/Regulatory Affairs. You ll be the technical backbone of quality on the manufacturing floor- driving continuous improvement, leading CAPA/NCR investigations, owning supplier quality and risk management, and stepping in as a key decision-maker when compliance and production intersect.

The company operates with a strong, values-driven culture built around integrity and accountability, the kind of place where doing things the right way isn t just policy, it s how people actually operate day to day.

• Real ownership from day one — this is a newly created seat with genuine influence over how quality operates, not a role where you re boxed into someone else s process
• Mission-driven, high-character culture — you ll work alongside people who take accountability seriously and treat their work as more than just a job
• Tangible impact — your work directly protects the safety of physicians and patients in real clinical settings, not abstract compliance for its own sake

• 3+ years of hands-on quality engineering experience in medical device manufacturing (or strong adjacent experience in a highly regulated industry)
• Fluency in ISO 13485, QSR, CAPA, and design controls — able to translate regulatory requirements into practical, floor-level action
• A proactive, "see it and fix it" mindset — someone who drives continuous improvement rather than just maintaining the status quo