Operations Quality Manager - Health Tech (Medical Devices)

Summary

This role requires a highly experienced Quality Assurance professional to lead all Quality activities within the HealthTech manufacturing site, ensuring robust compliance with global quality management systems (QMS) and rigorous customer regulatory requirements

Detailed Description

Process and Product Validation Leadership

• Oversee, lead, and drive all validation activities across the site, ensuring processes adhere to the Process Validation Process
• Lead the development and approval of validation protocols and documentation, including User Requirements Specifications (URS) and Test Scripts/Protocols, ensuring detailed specifications are met prior to customer review
• Ensure strict adherence to procedures for Installation Qualification (IQ), Operational Qualification (OQ), Process Performance Qualification (PQ), and Product Performance Qualification (PPQ)
• Manage the process for documenting Deviations (DEV) from established protocols
• Ensure all personnel performing validation activities are appropriately trained, competent, and formally authorized per the Training Matrix

Quality Management System & Compliance

• Maintain direct oversight and alignment with the customer's QMS facilitation team
• Act as a primary point of contact for customer technical and quality leadership, managing interfaces where requirements are subject to interpretation
• Ensure compliance with all customer quality expectations
• Be involved in the approval chain for Engineering Change Notifications (ECN) release and internal Corrective and Preventive Actions (CAPA)

Team Leadership & Continuous Improvement

• Lead and manage the QA team, assigning daily duties and ensuring execution meets customer requirements, including New Product Introduction (NPI) builds, Mass Production, and non-conformance issues.
• Create, revise, and provide QA Key Performance Indicators (KPIs) that reflect the company's Quality objectives
• Support NPI cadence across quality, engineering, and manufacturing to eliminate functional handoff delays
• Facilitate structured decision-making between the customer, internal teams, and executive leadership

Knowledge/Skills/Competencies

Validation Expertise:

• Extensive, hands-on experience and proven expertise in process validation, including the execution and approval of IQ, OQ, PQ, and PPQ protocols
• In-depth knowledge of developing detailed User Requirements Specifications (URS) and Test Scripts/Protocols that meet regulatory and customer expectations
• Knowledge in the requirements for verification and validation of computerized systems and spreadsheets, including controls for user access, lifecycle management, and compliance with electronic records regulations.
• Familiarity with industry validation frameworks

Regulatory & Standards Knowledge:

• Strong understanding of regulatory requirements and standards, including FDA Parts 11/820
• Expertise in ISO 13485 and ISO 9001, and familiarity with EU GMP/MDR and MDSAP (advantage)
• Proficiency in internal HealthTech QMS procedures related to risk management (Risk Management (FMEA HealthTech product), change control, and documentation

Experience & Skills:

• Demonstrated expertise in Quality Assurance and Quality Management Systems, preferably within the Medical Device manufacturing or other HealthTech regulated industries.
• Experience dealing with Quality Management Systems supporting at least Class I, Class II medical devices is valuable
• Proficiency in data-driven quality improvement using tools like Statistical Process Control (SPC), 8D, and Kaizen.
• Ability to use data analysis software such as Minitab, Excel Macro, and Access.
• Certifications such as Lean Six Sigma Black Belt are a plus.

Notes

This job description is not intended to be an exhaustive list of all duties and responsibilities of the position. Employees are held accountable for all duties of the job. Job duties and the % of time identified for any function are subject to change at any time.