Quality & Regulatory Manager

Role details

We’re looking for a hands-on Quality & Regulatory Manager who leads from the front. The ideal candidate brings medical device manufacturing and ISO 13485 experience, strong technical problem-solving and statistical skills, and the ability to work alongside the team to get things done. Experience with Cp/Cpk, DOE, validation documentation, root cause analysis, and continuous improvement is highly valued, with plastics injection molding experience a plus. Lean Six Sigma Green Belt or higher preferred. This is an excellent opportunity for a true “working manager” who enjoys balancing leadership with hands-on technical involvement.

KEY ACCOUNTABILITIES: (The broad spectrum of items that the role is ultimately held accountable for at the end of the day. Results.) We are seeking a hands-on Quality & Regulatory Manager to drive quality excellence, regulatory compliance, and continuous improvement within our medical device manufacturing operation. The ideal candidate will have strong experience in root cause analysis, CAPA management, and implementing sustainable corrective actions while fostering a culture of quality on the production floor. Experience with ISO 13485 is required, and medical device manufacturing and injection molding experience are strongly preferred.

This role requires a proactive leader who can influence change, improve processes, and partner closely with operations to achieve quality and business objectives. Quality Management Systems Internal Audits Continuous Improvement PPAP/ Validations Inspection Engineering Technician Project Management KEY RESPONSIBILITIES: (The finer details of what the role is assigned for the day-to-day activities on the job. Tasks to support results.) Oversee, maintain and continuously improve the QMS (Quality Management System) at the Minnesota facility. Ensure the appropriate QMS is updated to comply with newly released ISO standards.

Oversee and manage internal audit programs at the Minnesota facility in compliance with ISO 13485 standards. Drive continuous improvement strategies with focus on process improvements and the QMS. Support and maintain ISO standards. Ensure that organizational product quality levels are met utilizing company metrics and visuals to heighten employee awareness downstream. Interface with all departments to ensure customer requirements are understood and properly defined within the QMS. Oversee document control to ensure compliance with customer document requirements, QMS, ISO, and applicable regulatory agency requirements.

Manage Quality Department interface with our customers related to all customer requirements; such as, PPAP’s, Validations (IQ, OQ, PQ), complaints, SCAR’s, CAR’s, Customer Audits, and product quality requirements. Manage all product inspection activities, FAI, PPAP, Validation, In-Process, and final inspection. Develop and manage all quality related KPI’s. Support purchasing with supplier development, performance ratings and supplier audits. Develop and maintain a culture that recognizes employee contributions and encourages participation in improving the performance and success of the company.

Understands and proactively keeps on top of Quality Assurance trends, updates, and aligning best practices to customer quality needs Collaborate with company leadership team to define Quality related targets and meet objectives. Support Engineering Activities – Designing and Performing DOE, Product Testing, Quoting for New projects Project Management and new product support as needed LMA RESPONSIBILITIES: (Leadership, Management, Accountability) Yes Responsible for the overall direction, coordination, performance and evaluation of all quality assurance employees. Responsible for the supervisory activities in accordance with the organization’s policies and applicable laws.

Responsibilities include meeting company goals and metrics, interviewing, hiring, and training employees; planning, assigning, and directing work; appraisals, rewarding and disciplining employees.

QUALITIES FOR SUCCESS: (Wright Engineered Plastics Core Values, Education, Training, Certifications, Years of experience, other skills and abilities, Physical Requirements for the Role, etc.) Demonstrates Wright Engineered Plastics Core Values We are customer focused We execute We win together We are respectful 15 years’ experience in a manufacturing environment 7 to 10 years’ recent Quality management experience, preferably in a senior leadership capacity 5 to 10 years’ experience in plastic injection molding experience Self-starter with the ability to motivate others. Leader who is able to make decisions, but also comfortable delegating decision making when appropriate.

Good written and oral communication skills. Experienced in good manufacturing practices and quality initiatives and programs. In-depth experience with QMS systems including ISO 13485 and ISO 9001. Ability to develop and maintain a team oriented work environment. Strong working knowledge of injection molding processes. Demonstrated experience at implementing continuous improvement, lean or other process improvement techniques. Strategic thinker with experience in statistical analysis and identifying trends through data Travel to other work sites: up to 20% (Must have a personal vehicle with valid driver license)