Senior Quality Systems Engineer

SENIOR QUALITY SYSTEMS ENGINEER

Medical Device Design & Manufacturing • On-site • Reports to the Quality Manager

About the role

A growing medical device design-and-manufacturing company is hiring a Senior Quality Systems Engineer to serve as the technical anchor of its quality management system. Your work directly protects product integrity and patient safety: you'll keep the QMS running cleanly across the full product lifecycle - design controls, production, and post-market surveillance - in compliance with ISO 13485, FDA 21 CFR Part 820, and ISO 14971. This role has no direct reports, but you'll be the person teams turn to for quality, statistical, and regulatory guidance, and you'll mentor across the organization. You'll partner closely with Manufacturing, R&D / Design Engineering, Manufacturing Engineering, Supply Chain, and Regulatory Affairs, and act as a key point of contact for auditors and regulatory bodies (FDA, Notified Bodies) and clients.

If you want a senior seat with real influence, stop-ship authority, and the runway to raise the bar on quality across an entire company, this is it.

What you'll own
• Keep QMS requirements built into every stage of manufacturing and the product lifecycle - design control, production, and post-market surveillance - per ISO 13485, FDA 21 CFR Part 820, and other applicable regulations.
• Drive CAPAs and Nonconformance Reports (NCRs) from investigation to closure: lead root cause analysis, confirm containment and corrective actions, and document verification of effectiveness.
• Run the risk management process to ISO 14971 - hazard analysis, DFMEA, PFMEA, and risk controls - and keep risk files current throughout the product's life.
• Review and approve planned deviations and quality plans, ensuring each is justified, risk-assessed, time-bound, and compliant with internal procedures and regulatory expectations.
• Assess design and process changes for impact on product, compliance, and documentation (DHF, DMR, DHR), confirming every change is reviewed, risk-assessed, verified/validated, and approved under change control.
• Safeguard the accuracy and completeness of quality records - inspection data, test reports, risk files, CAPA files, and audit records - under document control requirements.
• Support product complaint handling end to end: investigation, documentation, and closure aligned with QMS procedures and regulatory reporting obligations.
• Serve as the QMS subject-matter expert in internal, external, and regulatory audits, presenting evidence of compliance and keeping the organization audit-ready year-round.
• Build quality plans, process controls, and metrics that reduce nonconformances, lift quality performance, and strengthen compliance over time.
• Provide technical leadership and mentoring across the organization, advancing strong QMS practices, sound manufacturing processes, statistical methods, and QMS software tools.
• Use your authority to halt production or hold material when you identify a quality or product nonconformance, and escalate critical issues to Quality Management.

What you'll bring
• A bachelor's degree in a science or engineering field - or an equivalent combination of education and relevant experience.
• At least 3 years of quality engineering experience in medical devices (or 5 years in a related manufacturing/assembly industry if you don't hold a degree).
• Working command of medical device regulations, including 21 CFR Part 820, ISO 13485, and ISO 14971.
• Strong applied statistics: control charts, sampling plans, quality costs, design of experiments, correlation, regression, analysis of variance, and probability.
• Clear written and verbal communication, with the ability to guide several cross-disciplinary projects at once.
• Comfort working independently and across functions with minimal oversight, plus strong leadership, collaboration, and attention to detail.
• Proficiency with standard office productivity and data-analysis software.

Nice to have
• ASQ Certified Quality Engineer (CQE).
• Hands-on experience with medical device design control, risk management, validation, and the full product lifecycle.
• Familiarity with FDA GMP practices, CAPA, and nonconforming material processes.
• Knowledge of MDSAP and EU MDD/MDR.
• Experience with LMS and eQMS software.

Work environment
• On-site role spanning office, cleanroom, and controlled manufacturing areas.
• Occasional travel for audits or supplier/customer engagements.
• Physical demands, performed with or without reasonable accommodation: primarily light work, with occasional medium-duty tasks during production-floor and audit support; sitting, standing, walking, reaching, grasping, and repetitive motion; close vision, color vision, depth perception, and the ability to adjust focus.