Title: Manager, Operational Quality
Location: Plymouth, MN
Job Type: Permanent/Direct-Hire
Compensation: $160,000 - $180,000 annually
Industry: Medical Equipment Manufacturing
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About the Role Our client is a globally recognized medical technology manufacturer specializing in noninvasive monitoring solutions used across hospitals, healthcare facilities, and home care settings. They are seeking a
Manager, Operational Quality to lead quality engineering, technical service, and post-market compliance functions across a growing portfolio of medical devices.
This leadership role is responsible for driving operational quality excellence, ensuring regulatory compliance, and supporting business objectives through effective quality systems, continuous improvement initiatives, and cross-functional collaboration. The successful candidate will oversee quality engineering teams, technical service operations, complaint handling, and post-market surveillance activities while helping to maintain compliance with global medical device regulations.
Job Description The Manager, Operational Quality provides strategic and operational leadership for quality engineering, technical service, and post-market compliance activities. This position partners closely with executive leadership, manufacturing, engineering, regulatory affairs, and customer-facing teams to ensure product quality, regulatory compliance, and customer satisfaction throughout the product lifecycle.
Key Responsibilities- Lead operational quality programs and ensure compliance with FDA Quality System Regulations (QSR), ISO 13485, EU MDR, and other applicable regulatory requirements.
- Manage Quality Engineering teams supporting product quality, manufacturing quality, and supplier quality initiatives.
- Oversee quality-related budgets, resources, and departmental performance objectives.
- Develop and implement quality processes that support manufacturing, supplier management, complaint handling, and post-market activities.
- Drive continuous improvement initiatives using risk-based decision-making and quality management principles.
- Ensure compliant execution of operational quality processes, including:
- Manufacturing process validation
- Design transfer activities
- Supplier quality management
- Complaint investigation and analysis
- Nonconforming product management
- Receiving and first article inspections
- Product storage and preservation requirements
- Environmental and materials compliance
- Lead regulatory inspections and external audits, including FDA and notified body audits.
- Partner with executive leadership on organizational strategy, governance, and operational planning.
- Develop and manage global technical service and support programs.
- Establish and execute strategies for product repairs, service reporting, customer support, and distributor training.
- Lead post-market compliance activities, including:
- Medical Device Reporting (MDR)
- Vigilance reporting
- Post-Market Surveillance (PMS)
- Product Safety Update Reports (PSUR)
- Field actions and recalls
- GUDID and EUDAMED compliance
- Device registrations and listings
- Support new product development and sustaining engineering programs as a quality and post-market compliance subject matter expert.
- Build, coach, and develop high-performing teams while fostering a culture of quality, accountability, and collaboration.
- Ensure technical training programs and service documentation are accurate, current, and compliant.
QualificationsRequired- Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline, or equivalent combination of education and experience.
- 7+ years of experience in medical device quality, compliance, technical service, or a regulated life sciences environment.
- Minimum 3 years of leadership or people management experience.
- Strong knowledge of:
- FDA Quality System Regulations (QSR)
- ISO 13485
- EU MDR/MDD requirements
- Medical device quality systems and post-market compliance
- Experience leading quality engineering, technical service, or compliance teams.
- Demonstrated success driving operational quality initiatives and achieving organizational objectives.
- Strong understanding of risk-based quality management principles.
- Excellent written and verbal communication skills, including experience interacting with regulatory agencies and certification bodies.
- Ability to interpret regulations, standards, and quality system requirements and apply them effectively across the organization.
- Proven ability to build, develop, and motivate high-performing teams.
- Ability to manage multiple priorities in a fast-paced, highly regulated environment.
Preferred- Advanced experience with medical device technologies, clinical applications, or patient monitoring systems.
- Experience leading global technical service organizations.
- Direct experience managing FDA inspections, ISO audits, and notified body audits.
- Experience supporting QMS remediation or quality system improvement initiatives.
- Background participating in new product development and design transfer projects.
- Familiarity with global post-market surveillance and regulatory reporting programs.
- Professional certifications in quality, compliance, or continuous improvement disciplines are a plus.
Work Environment & Physical Requirements- Ability to sit and/or stand for extended periods throughout the workday.
- Occasional bending, stooping, or kneeling as required.
- Ability to work in an office, laboratory, manufacturing, or regulated medical device environment.
Benefits Our client offers a comprehensive benefits package designed to support your overall well-being and long-term success, including health and wellness coverage, competitive compensation, and financial security through 401(k) matching, profit sharing, and flexible spending and health savings accounts. Employees also receive personal protection benefits such as life and disability insurance, along with a strong focus on work-life balance through paid time off (PTO), paid parental leave (PPL), and company-paid holidays. Additionally, they are committed to your growth by providing ongoing professional development opportunities.
How to Apply Take the first step on your new career path!
To submit yourself for consideration for this role, simply click the apply button and complete our mobile-friendly online application. Once weve reviewed your application details, a recruiter will reach out to you with next steps!
Equal Opportunity Statement As an equal opportunity employer, Dahl Consulting welcomes candidates of all backgrounds and experiences to apply. If this position sounds like the right opportunity for you, we encourage you to take the next step and connect with us. We look forward to meeting you!
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