Quality Manager

• Discretionary Time Off
• Employee bonus plan
• Flexible hybrid/remote work options
• Full pay maternity paternity parental short-term disability leaves
• Employee driven recognition program
• Access to hundreds of training opportunities
• Company paid educational assistance
• Well-being on demand
• Perks at Work
• Competitive health and welfare plans -HSA company contribution
• 401(k) company match
• Great culture and people!

• Collaborate with upper management to support quality objectives and execution of defined quality priorities.
• Provide leadership for Electromeds 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.

• 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.
• Must live within commutable distance to New Prague MN.
• Ability to travel <10%.

Be You.

Our people celebrate diverse individuals backgrounds and thinking. As an equal opportunity

employer this is the absolute most important belief in cultivating our culture and growth together.

Core Values

Customer-Focused. Integrity. Resourceful. Collaborative. Results-Driven.

Electromed develops manufactures and markets innovative airway clearance devices that help

people around the world breathe better stay healthier and lead active and fulfilling lives.

Making Lifes important moments possible-one breath at a time.

All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability or status as a protected veteran.