Quality Manager
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Overview
Schedule
Full-time
Education
Engineering (PE)
Career level
Director
Remote
Hybrid remote
Compensation
$115,000-$150,000/year
Benefits
Disability Insurance
Family/Dependent Health
Paid Vacation
Job Description
People Purpose: Beyond CompetitiveIt is no longer ok to just be competitive regarding how we treat our people in everything we do. Our leadership team believes wholeheartedly we need to be beyond competitive and cultivate a culture of proud, driven employees who are passionate about the work they do and where they do it. Our leadership strives to unleash unsurpassed potential in every team and individual employed and owns making that happen. Sincere, Simple, Smart.What makes us Beyond Competitive:
- 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 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.
- 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 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. Additional benefits include performance-based incentives, comprehensive health benefits, retirement savings options, paid time off, and opportunities for professional growth and development. Benefits eligibility and offerings may vary based on role and location.
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 Life’s 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.
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FAQs About Quality Manager Jobs at Electromed Inc.
What is the work location for this position at Electromed Inc.?
This job at Electromed Inc. is located in New Prague, MN, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Electromed Inc.?
Candidates can expect a pay range of $115,000 and $150,000 per year.
What employment applies to this position at Electromed Inc.?
Electromed Inc. lists this role as a Full-time position.
What experience level is required for this role at Electromed Inc.?
Electromed Inc. is looking for a candidate with "Director" experience level.
What education level is required for this job?
The education requirement for this position is Engineering (PE). Candidates with relevant qualifications or equivalent experience may also be considered.
What benefits are offered by Electromed Inc. for this role?
Electromed Inc. offers following benefits: Disability Insurance, Family/Dependent Health, Paid Vacation, Parental and Family Leave, Career Development, 401k Matching/Retirement Savings, Tuition/Education Assistance, and Health & Wellness Programs for this position. Actual benefits may vary depending on the employer's policies and employment terms.
What is the process to apply for this position at Electromed Inc.?
You can apply for this role at Electromed Inc. either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.