Quality Manager- MED DEVICE ISO13485

Quality Manager

Position Summary

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