Medical Quality Manager
PMC Smart Solutions LLC
Summary
PMC SMART Solutions is hiring a Quality Manager to lead daily production quality operations, develop a high-performing team, and drive a culture of accountability, ownership, and continuous improvement. This is an opportunity to make a meaningful impact across PMC's Medical operations — strengthening quality performance, leading cross-functional problem-solving efforts, and ensuring we consistently deliver on our commitment to quality and customer satisfaction.
Job description
What You'll Do
As Quality Manager, you'll lead the daily operations of the Quality Department, developing people, optimizing resources, and partnering across the organization to resolve quality concerns, strengthen processes, and support PMC's zero-defect objectives.
Leadership, Team Development & Accountability
- Lead daily Quality Department operations, ensuring resources are effectively utilized and production quality activities consistently meet PMC's standards and zero-defect objectives.
- Coach, develop, and lead Quality team members by establishing clear expectations, strengthening individual capabilities, and fostering ownership and accountability.
- Partner with the Quality Supervisor to evaluate team performance, productivity, staffing, and effectiveness across 24-hour production operations.
- Ensure appropriate Quality Lead coverage across shifts, promoting consistent communication, clear ownership, and timely escalation of quality concerns.
- Provide guidance and technical support on escalated production quality issues, helping the team make informed decisions that protect product integrity and maintain operational continuity.
- Oversee departmental performance, workforce allocation, and resource utilization, identifying opportunities to improve efficiency and strengthen team effectiveness.
Internal & External Communication
- Serve as a key point of contact for internal and external quality-related matters, communicating professionally and promptly to reinforce PMC's commitment to quality and customer satisfaction.
- Partner with the Director of Quality and Customer Quality Representatives to address customer complaints, product returns, investigation findings, and corrective action plans.
- Collaborate with operational leadership, Engineering, Manufacturing, and other cross-functional partners to evaluate quality concerns and align on appropriate next steps.
- Work closely with the Medical Business Unit Manager and operational leaders to assess production quality issues and determine appropriate actions, including production interruptions when necessary.
- Build strong working relationships across departments, promoting open communication, shared accountability, and alignment with PMC's core values.
Root Cause Analysis & Quality Issue Resolution
- Lead structured, cross-functional problem-solving efforts to identify root causes, establish corrective actions, and prevent recurring quality issues.
- Apply established problem-solving methodologies, including Eight Disciplines (8D), Five Whys, and fishbone analysis, to drive effective, data-driven decisions.
- Oversee the documentation and follow-through of corrective and preventive actions (CAPA), ensuring issues are addressed systematically and corrective measures are effective.
- Partner with the Director of Quality to prioritize customer complaints and Return Material Authorizations (RMAs), coordinating timely investigations, corrective actions, and rework activities.
- Work with the Quality Supervisor and Sustaining Quality Lead to identify recurring production concerns, review nonconformance documentation, and ensure appropriate escalation and resolution.
- Collaborate with the Supplier Quality Engineer to investigate supplier-related quality issues and support corrective action efforts that prevent recurring defects.
Continuous Improvement & Department Innovation
- Partner with the Director of Quality to identify and lead continuous improvement initiatives that strengthen departmental processes and improve first-pass quality.
- Challenge existing practices and encourage the Quality team to identify inefficiencies, develop practical solutions, and eliminate recurring problems rather than relying on temporary workarounds.
- Translate improvement opportunities into structured, measurable actions supported by appropriate validation reports, updated documentation, and effective implementation practices.
- Collaborate with the Quality Supervisor to strengthen shift changeover meetings, ensuring important quality concerns, priorities, and improvement opportunities are consistently communicated.
- Evaluate the effectiveness of implemented improvements and incorporate lessons learned into departmental practices to sustain progress and strengthen customer satisfaction.
What You Bring
Experienced quality professionals with a proven ability to lead teams, drive accountability, resolve complex quality issues, and foster a culture of continuous improvement within a manufacturing environment. Specific experience, education, and technical qualifications to be determined.
Requirements
- Experienced quality professional
- Proven ability to lead teams
- Ability to drive accountability
- Ability to resolve complex quality issues
- Experience fostering continuous improvement in a manufacturing environment
Benefits
- Competitive compensation
- Comprehensive benefits package
- Professional development
- Mentorship
- Cross-functional exposure
- Career growth path
Company overview
PMC Smart Solutions LLC is a fourth-generation family-owned contract manufacturing company specializing in precision plastic injection molding and assembly solutions for the medical device and automotive industries. Founded in 1929 and headquartered in Cincinnati, Ohio, the company leverages over 90 years of manufacturing expertise to deliver complex, high-precision components that meet stringent quality and safety standards. As an FDA-registered and ISO 13485 certified manufacturer, PMC provides comprehensive services including product development engineering, tool building, Class 8 clean room manufacturing, electromechanical assembly, sterile packaging, and sterilization management. The company serves as a strategic supplier to major medical device manufacturers like Medtronic, producing implantable and non-implantable components for orthopedic, spine, cardiovascular, and drug delivery applications. With facilities in Ohio and Indiana, PMC combines its automotive safety component manufacturing heritage with advanced medical device production capabilities, operating under the core values of REAL Insight, REAL Attention, and REAL Confidence to deliver life-saving technologies.