- Serve as FDA Management Representative with final quality decision authority and responsibility for regulatory compliance and QMS effectiveness
- Own, maintain, and continuously improve the ISO 13485 and ISO 9001-certified QMS, including leading audits, CAPAs, and management reviews
- Establish and oversee part and product inspections and release activities, including direct execution as needed and final review/approval of delegated acceptance decisions
- Oversee supplier qualification, monitoring, and compliance with regulatory and quality requirements, and serve as the U.S. Agent for designated foreign suppliers
- Direct and coordinate internal resources, in collaboration with functional leaders, to meet quality and regulatory objectives
- Analyze quality data, trends, and risk using appropriate statistical methods
- Drive quality culture and cross-functional engagement by promoting a customer- and patient-oriented culture (weighEasier) and communicating quality objectives and risks across the organization
- Travel up to 5%
- Bachelor's degree required. Engineering, Science, or a related technical field preferred. Additional relevant education is a plus.
- 6+ years of quality/regulatory experience in a regulated environment, including 4+ years in medical devices within a certified quality system (e.g., ISO 13485)
- Demonstrated experience owning quality and/or regulatory processes and final decisions
- 10+ years of technical, quality, or regulatory experience in medical devices
- Prior experience serving as FDA Management Representative
- Experience managing team or external vendors with demonstrated independent decision authority
- Strong statistical analysis background – ASQ, RAPS, Lean, or similar certifications preferred
- Experience with similar technologies to existing product families
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Quality Manager - La Grange - Pelstar LLC/Health o meter Professional Scales
21 minutes ago
Description
Pelstar LLC is an ISO 13485 and ISO 9001-certified manufacturer of Class I medical devices under the Health o meter Professional and Bridge Healthcare brands. We are seeking a motivated quality professional to own and lead quality and regulatory as the company's Quality Manager. Our products, trusted across the full continuum of care—from physician offices and long-term care facilities to acute care and ambulatory surgery centers—are distributed across North America and extend globally into South America, the Middle East, and Asia.
Role Overview: The Quality Manager serves as the company's authority for quality and regulatory compliance, operating in close partnership with Engineering and executive leadership. The role holds final quality decision authority for product release, supplier qualification, and process changes. This is a primarily on-site, hands-on leadership role with limited flexibility based on business needs responsible for ensuring effective execution of QMS processes and data-driven quality decisions. This position reports to the head of Engineering, with direct and regular engagement with the CEO/President to ensure alignment on quality and regulatory priorities. The role currently has no direct reports and leverages internal and external support resources to support QMS activities.
Key Responsibilities:
Required Qualifications:
Preferred Qualifications:
Compensation and Benefits: We offer a competitive compensation package, including a comprehensive suite of health benefits, tailored to support the wellbeing of our team members and their families.
Location: On-site, McCook, IL 60525
Join Us: We welcome your application. Please send your resume to
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