Minnetronix Medical · 1 day ago
Quality Supervisor
St Paul, MN
Full-time
Onsite
Mid, Senior Level
3+ years expForj Medical is a company dedicated to bringing life-enhancing medical technologies to market. The Quality Supervisor will lead the strategic direction and execution of Quality Control operations, ensuring compliance with regulatory standards while driving operational excellence across multiple QC teams.
Health CareManufacturingMedical DeviceProduct Design
Responsibilities
Develop and implement a long-term QC strategy aligned with corporate goals, product roadmap, and global compliance requirements
Serve as a key member of the Quality Leadership team, contributing to organizational strategy, quality planning, and resource allocation
Establish enterprise-wide QC standards, metrics, and performance benchmarks to ensure robust and scalable quality systems
Ensure full compliance with all compliance and regulatory requirements including ISO 13485, FDA, and 21 CFR Part 820
Ensure team is completing all requirements of qualification plans (IQ, OQ, PQ) and reports to assure components, materials and suppliers meet specified requirements and performance, reliability and safety goals
Lead and supervise all QC functions including incoming inspection, in-process testing, final QC release, stability testing, and lab operations
Oversee creation, revision, and approval of SOPs, work instructions, specifications, and control plans
Lead QC readiness for audits; act as SME (subject matter expert) for QC processes
Ensure state-of-the-art testing methodologies, equipment qualifications, and data integrity practices
Support design transfer, new production introductions (NPI), and process validation activities
Ensure robust root cause analysis, CAPA development, and timely closure of quality events
Additional duties as assigned
Qualification
Required
Bachelor's degree in quality engineering or related field or equivalent work experience
Three to five years of experience in quality management, quality, or manufacturing engineering
Experience in an ISO 13485 Medical Device Quality System is required
Deep knowledge of global medical device regulations
Strong background in product testing, statistical methods, and quality engineering principles
Ability to lead change in complex and fast-paced manufacturing environments
Leadership in supporting regulatory audits and driving cross-functional alignment
Strong problem-solving skills, root cause analysis and corrective action investigations are a must
Preferred
Lean Sigma experience desired
CQE certification is a plus
Working knowledge of Minitab statistical software, a plus
Benefits
Health
Dental
Vision
401K plans
Time off programs
Annual bonus program
Company
Minnetronix Medical
Minnetronix Medical develops, manufactures, and commercializes medical device technologies.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$20MKey Investors
Altaris Capital Partners
2025-10-08Acquired
2021-02-03Private Equity
2016-01-26Series Unknown· $20M
Leadership Team
Jonathan Pierce
VP, Corporate Affairs
Stan Crossett
VP Manufacturing
Recent News
2025-12-13
2025-10-10
Company data provided by crunchbase