The Quality Manager is responsible for leading Quality Assurance and Quality Control activities across a medical injection molding facility undergoing product and equipment transfers and eventual site closure, while also overseeing and establishing the Quality Management System (QMS) for a nearby dip molding operation (medical and industrial) that will remain operational.
This role ensures continued compliance to ISO 13485 and ISO 9001 standards, supports validation and transfer activities, and maintains product quality and customer confidence during a critical transition period. The Quality Manager will lead a team of quality engineers and inspectors, partner closely with Operations and Project Management, and serve as a key link between sending and receiving sites.
Key Responsibilities
Quality Leadership & Team Management
Lead, mentor, and develop a team of Quality Engineers and Inspectors across both sites
Maintain strong floor presence to ensure adherence to quality standards and support production
Foster a culture of accountability, quality ownership, and continuous improvement
Provide clear communication and stability to the team during site transition and organizational change
Site Transfer & Validation Support
Lead quality activities related to product and process transfers, including validation strategy and execution (IQ/OQ/PQ)
Partner with Project Managers and cross-functional teams to ensure successful transfer of products, processes, and documentation
Ensure all Device History Records (DHRs), Device Master Records (DMRs), and validation documentation are complete, accurate, and transfer-ready
Act as the quality "voice of the sending site," ensuring risks are identified, mitigated, and communicated
Support receiving site readiness, including documentation clarity and knowledge transfer
Plant Closure & Compliance
Ensure quality and regulatory compliance is maintained through all phases of site wind-down
Support product final builds, documentation closure, and record retention requirements
Participate in audit readiness and support customer/regulatory audits related to transfer and closure activities
Ensure compliant decommissioning of processes and equipment
Dip Molding Site – QMS Development & Oversight (Tempe, AZ)
Lead the development, implementation, and ongoing management of a fit-for-purpose QMS for the dip molding site (medical and industrial products)
Establish procedures, work instructions, and quality standards aligned with ISO 13485 and ISO 9001 as applicable
Ensure appropriate scalability of the QMS to support both regulated medical and industrial business lines
Train site personnel and build quality capabilities to sustain long-term operations
Oversee ongoing quality performance, audits, and compliance at the dip molding site
Regulatory & Customer Compliance
Ensure compliance with ISO 13485, ISO 9001, FDA requirements, and customer-specific requirements
Serve as primary point of contact for customer quality issues, audits, and communications
Prepare and manage documentation for internal and external audits and inspections
Maintain strong customer confidence throughout transfer and transition activities
Operational & Cross-Functional Collaboration
Partner closely with the Operations Manager to align production, quality, and transfer priorities
Collaborate with Engineering, Supply Chain, and Customer Service to resolve quality issues and support business objectives
Provide quality input into production planning, risk management, and decision-making
Candidates with operations or manufacturing leadership experience are highly valued
Data, Problem Solving & Continuous Improvement
Analyze quality and process data to identify trends, risks, and improvement opportunities
Lead root cause investigations and drive effective corrective and preventive actions (CAPA)
Implement initiatives to improve product quality, reduce scrap, and enhance process capability
Drive a pragmatic, risk-based approach to quality during transition and steady-state operations
Key Competencies
Quality Systems Leadership – Builds, scales, and sustains compliant and effective QMS
Transfer & Validation Expertise – Deep understanding of product/process transfers and validation requirements
Change & Transition Leadership – Maintains performance and engagement during uncertainty
Regulatory Acumen – Strong working knowledge of ISO 13485, ISO 9001, and FDA expectations
Cross-Functional Collaboration – Works seamlessly with Operations, Engineering, and PM teams
People Leadership – Develops teams, drives accountability, and maintains morale
Problem Solving & Risk Management – Uses data-driven, practical decision-making
Communication & Customer Focus – Builds trust internally and externally
Qualifications
Bachelor's degree in Engineering, Quality, or related technical field
7–10+ years of quality experience in medical device manufacturing, with injection molding experience strongly preferred
Prior leadership experience managing quality teams in a regulated environment
Experience supporting product transfers, validations, and/or site closures highly preferred
Demonstrated experience building or significantly enhancing a Quality Management System
Strong knowledge of ISO 13485, ISO 9001, and FDA Quality System Regulations
ASQ Certification (CQE, CQM) preferred
Work Environment & Additional Requirements
Combination of manufacturing floor and office environment across two nearby sites
Hands-on role requiring regular floor engagement
Ability to travel between sites as needed
May require flexibility in hours to support production, validation, and transfer milestones