Medical Device Quality Systems Engineer (ISO 13485)

Medical Device Quality Systems Engineer (ISO 13485)

Step into a role where your day blends technical depth with cross-functional leadership. You start by triaging quality issues: organizing containment, mapping root causes, and driving effective corrective actions that protect both internal operations and external customers. By mid-morning, you’re collaborating with suppliers and customers to untangle a tricky nonconformance, reviewing First Article Inspection results, and interpreting complex drawings and specifications to guide a robust product or process implementation.

Afternoons shift to system stewardship and rigor. You maintain and elevate our Quality Management System to align with ISO and regulatory standards, support external audits and factory inspections, and participate in our Internal Quality Auditing program. You author and review IQ/OQ/PQ validation protocols and reports, refresh SOPs, work instructions, and controlled forms, and lead PFMEA, Control Plan, and process flowchart working sessions with cross-functional partners. Throughout, you design and validate quality databases, analyze trends, and communicate insights that steer continuous improvement projects to reduce defects and raise overall product quality. You also provide guidance and training on Quality procedures, GMP, and GDP to strengthen our culture of compliance.

What you'll handle

• Lead structured problem-solving to determine containment, root cause, and corrective actions for internal and external customers
• Interface with customers and suppliers to resolve quality issues and support investigations
• Perform internal investigations for complaints/deficiencies and drive cross-functional teams to resolution and disposition
• Review and disposition Nonconforming Material Reports (NCMRs) and First Article Inspections (FAIs)
• Maintain and improve the QMS to ensure compliance with ISO and regulatory expectations
• Support external customer, supplier, and regulatory audits and factory inspections; participate in Internal Quality Auditing
• Interpret complex drawings, documents, and specifications for effective product/process implementation
• Generate and review IQ, OQ, and PQ validation protocols and reports for adequacy and compliance
• Contribute to Quality Planning for contract review, new product introduction, and system improvements
• Create/update SOPs, Work Instructions, and controlled forms
• Plan and execute continuous improvement initiatives to reduce defects and improve product quality
• Design/validate quality databases, queries, and reports; manage and maintain quality data
• Prepare, present, review, and analyze quality metrics to identify trends and conclusions
• Provide oversight and training on Quality procedures, GMP, GDP, and related practices
• Facilitate PFMEAs, Control Plans, and Process Flowcharts with cross-functional teams

Your background

• Quality engineering experience in medical devices and/or biotechnology (or equivalent)
• Bachelor’s degree in engineering, sciences, or a technical discipline
• Hands-on familiarity with the medical device environment
• Mechanical engineering exposure and understanding of a machine shop environment is a plus
• Strong blueprint interpretation and Geometric Dimensioning & Tolerancing (GD&T) skills
• Excellent verbal and written communication
• Advanced math/statistics knowledge; experience with statistical software (e.g., Minitab) is a plus
• Background in APQP, PPAP, and practical work with Process Flow Charts, PFMEAs, and Control Plans
• Advanced computer proficiency; strong Microsoft Office skills
• Basic knowledge of ISO 9001 and ISO 13485; FDA knowledge is a plus
• Certified Quality Auditor (CQA) and/or Certified Quality Engineer (CQE) is a plus

Schedule & compensation

Hours: Monday through Friday – 8am to 4:30pm

Compensation: Salaried position, $75,000–$95,000 based on experience