Quality Manager

About the role

The Quality Manager role is critical to sustaining ISO 13485 compliance, supporting FDA and other external audits, and driving follow-up and closure of key quality system activities.

Responsibilities

• Collaborate with upper management to support quality objectives and execution of defined quality priorities.
• Provide leadership for Electromed’s ISO 13485 Quality System and support ongoing successful audits.
• Participate in and lead, as applicable, internal audits, FDA inspections, notified body audits, and other external assessments.
• Supervise and develop the Quality Engineer and Quality Technician, including prioritization of day-to-day quality activities.
• Own and oversee the Supplier Quality Management program.
• Monitor supplier quality performance metrics and scorecards.
• Lead or oversee periodic supplier re-evaluations.
• Lead escalation and resolution of significant supplier quality issues in partnership with Quality Engineering, Operations, Supply Chain, and suppliers.
• Provide direction for supplier-related nonconformances, containment, disposition strategy, and corrective action follow-up, as needed.
• Provide oversight for inspection activities, including review and approval of higher-risk inspection plan changes and related escalations.
• Develop, revise, and implement quality system procedures, work instructions, and related process improvements.
• Support CAPA, nonconformance, deviation, and investigation activities, ensuring timely follow-up and closure of assigned actions.
• Partner with Operations, Engineering, and Regulatory to address quality issues affecting released product and supplier-related quality concerns.
• Provide quality-system and product-quality input, including hands-on technical support as needed, to Engineering, Operations, and Design Assurance on supplier issues, product changes, sustaining activities, investigations, and validation-related matters.
• Monitor and communicate key quality system and supplier quality risks and trends to management.
• Act as the company Quality Management Representative, as assigned.

Requirements

• Preferred degree in Quality Engineering, Engineering, Regulatory Affairs, or a related field.
• Minimum of 8 years of experience in the medical device industry preferred.
• At least 5 years of managerial or supervisory experience.
• Significant experience in FDA-regulated industry.
• Proven experience leading FDA inspections and ISO 13485 audits.
• Strong knowledge of key regulatory standards, including ISO 14971 (Risk Management), ISO 13485 (Quality Management Systems), IEC 60601-1 (EMC and Safety), European Union MDR, and FDA 21 CFR 820.
• Experience leading or overseeing supplier quality activities, including supplier performance monitoring, supplier issue escalation, and supplier re-evaluation.
• Familiarity with Process Excellence, Six Sigma, and Lean methodologies is preferred.
• Proficient in technical drawings, schematics, computer technology, and Microsoft Office applications.
• Exceptional analytical and problem-solving abilities.
• Able to define objectives for a cross-functional team and manage timely execution.
• Must live within commutable distance to New Prague, MN.
• Ability to travel.

Pay

The salary range for this position is $115,000-$150,000 annually with the final agreed upon compensation to be based on individual experience, skills, and qualifications.

Schedule

This is a hybrid opportunity based in New Prague, MN.