Quality Manager - Medical Device / ISO 13485

Location:

Trevor, WI Job Type:

Full-Time Industry:

Medical Device / Regulated Manufacturing Position Overview We are seeking an experienced, hands-on Quality Manager to lead and continuously improve an

ISO 13485

Quality Management System (QMS) within a fast-paced, regulated manufacturing environment. This position will serve as the site quality leader and work closely with Operations, Engineering, Supply Chain, and Customer Service to maintain regulatory compliance, strengthen quality performance, support continuous improvement, and ensure customer requirements are consistently met. The ideal candidate has strong experience in medical device manufacturing, medical/healthcare packaging, or another highly regulated manufacturing environment and is comfortable balancing QMS leadership with day-to-day operational quality support. Key ResponsibilitiesQuality Management System (QMS) Lead, maintain, and continuously improve the

ISO 13485

Quality Management System . Ensure compliance with applicable regulatory, customer, and internal quality requirements. Serve as the site's Quality Management Representative. Manage document control and quality record retention processes. Coordinate Management Reviews and present key quality metrics and performance trends. Establish, monitor, and drive completion of quality objectives. Maintain ongoing audit and inspection readiness. CAPA & Nonconformance Management Lead the Corrective and Preventive Action (CAPA) program. Manage investigations and ensure timely closure of quality issues. Facilitate root cause analysis and corrective action activities. Monitor and verify the effectiveness of corrective actions. Oversee nonconforming material/product processes and disposition activities. Identify recurring quality trends and implement preventive improvements. Risk Management Ensure risk management activities align with

ISO 14971

requirements. Participate in risk assessments for products, processes, equipment, suppliers, and manufacturing changes. Support the implementation and verification of risk controls. Ensure risk management documentation remains accurate and current. Validation & Quality Engineering Review and approve validation protocols and reports. Support

IQ/OQ/PQ

validation activities . Partner with Engineering and Operations on process improvements and process capability initiatives. Ensure manufacturing and process changes are properly evaluated, documented, and validated. Audits & Regulatory Compliance Manage the internal audit program. Coordinate customer, certification, supplier, and regulatory audits. Serve as a primary quality contact during external audits and inspections. Track audit findings and corrective actions through successful closure. Maintain continuous readiness for

ISO 13485

certification audits. Supplier Quality Manage supplier qualification, monitoring, and performance programs. Conduct or coordinate supplier audits. Manage Supplier Corrective Action Requests (SCARs) . Support supplier risk assessments and supplier change-control activities. Partner with Supply Chain to improve supplier quality performance. Customer Quality & Complaint Management Lead customer complaint investigations and corrective actions. Ensure complaint-handling processes meet applicable regulatory requirements. Analyze complaint trends and implement improvement initiatives. Serve as the primary escalation point for significant customer quality concerns. Support customer communication related to quality issues and corrective actions. Quality Leadership & Training Lead, coach, and develop Quality Specialists, Technicians, Auditors, and Inspectors. Establish departmental goals, priorities, and performance expectations. Manage quality department resources effectively. Ensure employee training meets regulatory and QMS requirements. Verify competency for quality-critical activities. Promote a strong culture of quality, accountability, compliance, and continuous improvement throughout the organization. QualificationsRequired Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences , or a related field. 5+ years of progressive Quality experience within a regulated manufacturing environment. 3+ years of direct experience with

ISO 13485

Quality Management Systems. Demonstrated experience leading internal, customer, and certification audits.

Strong knowledge of:

ISO 13485 CAPA

Nonconformance management Root cause analysis Change control Supplier quality Complaint investigations Document control Validation activities Previous experience leading or developing quality personnel. Preferred Medical device manufacturing or medical/healthcare packaging experience. Experience within an FDA-regulated manufacturing environment . Knowledge of

ISO 14971

Risk Management . Experience with

IQ/OQ/PQ

validation . Supplier auditing and SCAR experience. Ideal Candidate The successful candidate will be: A strong, hands-on quality leader who can operate at both strategic and operational levels. Highly organized with excellent attention to detail. An effective communicator capable of working with employees, leadership, customers, suppliers, and auditors. Experienced in root cause analysis and structured problem-solving. Comfortable making risk-based decisions within a regulated manufacturing environment. Able to balance regulatory compliance with production and operational requirements. Proactive in identifying opportunities to improve quality, processes, and customer satisfaction. Key Measures of Success Successful maintenance of

ISO 13485

certification . Timely and effective CAPA closure. Reduction in customer complaints and internal quality issues. Successful internal, customer, regulatory, and certification audits. Improved supplier quality performance. On-time completion of Management Reviews and Quality Objectives. Continued improvement in overall QMS effectiveness. Physical Requirements Ability to perform activities including standing, walking, reaching, pushing, pulling, grasping, typing, talking, hearing, and repetitive motions. Frequent use of hands to handle tools, equipment, products, and controls. Ability to occasionally lift and/or move up to 40 pounds . Ability to perform work requiring close vision and adjustment of focus. Why Join Us? This is an excellent opportunity for an experienced Quality professional to take ownership of a critical quality function within a growing regulated manufacturing environment. You will have the opportunity to influence quality strategy, develop teams, strengthen systems, and drive improvements that directly impact customers and manufacturing performance. key

Skills:

Quality Manager | Medical Device Quality Manager |

ISO 13485

Quality Manager | Quality Assurance Manager | QA Manager | Quality Systems Manager | QMS Manager | Medical Device Manufacturing | Medical Device Quality |

ISO 13485

| FDA Compliance | FDA Regulated Manufacturing | Quality Assurance | Quality Control | Regulatory Compliance | CAPA | Corrective and Preventive Action | Nonconformance | NCR | Root Cause Analysis |

ISO 14971

| Risk Management | Internal Audits | Regulatory Audits | Supplier Quality | Supplier Quality Management | SCAR | Supplier Audits | Validation |

IQ OQ PQ

| Process Validation | Complaint Handling | Customer Quality | Document Control | Change Control | Quality Engineering | Quality Systems | GMP | cGMP | Continuous Improvement | Healthcare Packaging | Medical Packaging | Regulated Manufacturing | Quality Leadership | Quality Management System | QMS | Wisconsin Manufacturing Jobs | Trevor WI | Kenosha WI Apply today if you have strong

ISO 13485

experience and are ready to take the next step in Quality leadership.

Pay:

$96,086.12 - $115,716.62 per year

Benefits:

401(k) Dental insurance Health insurance Life insurance Paid time off Vision insurance

Education:

Bachelor's (Required)

Experience:

quality manager : 5 years (Required)

Medical Device:

5 years (Required)

ISO 13485

3 years (Required)

Work Location:

In person