Quality Manager

Electromed Inc.•New Prague, MN

1d•$115,000 - $150,000•Hybrid

About The Position

The Quality Manager provides focused leadership for Electromed’s Quality Management System, supplier quality oversight, audit readiness, and inspection oversight. This role supervises the Quality Engineer and Quality Technician and partners closely with Operations, Engineering, Supply Chain, Regulatory, and Quality to support compliance, product quality, and efficient execution of defined priorities. This position is critical to sustaining ISO 13485 compliance, supporting FDA and other external audits, and driving follow-up and closure of key quality system activities.

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.
Ability to define objectives for a cross-functional team and manage timely execution.
Ability to travel <10%.

Nice To Haves

Familiarity with Process Excellence, Six Sigma, and Lean methodologies is preferred.

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.