Manager, Operations Quality - NPI Programs

Manager, Operations Quality - NPI Programs (Hybrid - Acton)

Job Summary

Join a highly visible leadership role where you will shape quality strategy for next-generation medical device products from early development through commercialization. As the Operations Quality Lead, you will lead both Manufacturing Quality and Supplier Quality activities, build and develop a high-performing quality team, and partner closely with R&D, Engineering, Operations, and suppliers to ensure compliant, scalable, and production-ready processes. This position offers the opportunity to drive supplier readiness, pilot manufacturing, clinical builds, and manufacturing transfer while influencing key quality decisions in a fast-paced, innovation-focused environment. Ideal candidates will bring expertise in quality engineering, supplier quality, FDA/ISO 13485 compliance, and NPI programs, along with a passion for leadership, problem-solving, and building robust quality systems that support successful product launches.

Position Overview: The Operations Quality Lead, NPI Programs is responsible for leading Operations Quality support across Manufacturing Quality and Supplier Quality activities for early-stage product development, supplier readiness, and pilot manufacturing operations.

This role serves as the single Operations Quality point of contact for manufacturing quality systems and supplier quality engineering support, ensuring prototype, pilot, clinical, and early commercial builds are compliant, well-controlled, and supported by capable suppliers, inspection strategies, and scalable quality processes.

Working closely with R&D, Manufacturing Engineering, Operations, Global Quality Engineering, and Global Supplier Quality, this role ensures builds are executed in compliance with design controls, supplier controls, documentation requirements, and regulatory standards while building the foundation for scalable, production-ready quality systems.

A critical responsibility is building and leading a small Operations Quality team that can cover Manufacturing Quality and Supplier Quality needs while maintaining dotted-line alignment to the global Quality Engineering and Supplier Quality organizations.

Responsibilities

• Serve as the Operations Quality lead for Manufacturing Quality and Supplier Quality Engineering support across early-stage development, supplier readiness, pilot manufacturing, clinical builds, and manufacturing transfer
• Build, manage, and develop a small team responsible for covering Manufacturing Quality and Supplier Quality activities for NPI programs
• Maintain strong dotted-line relationships with Global Quality Engineering and Global Supplier Quality to ensure alignment with enterprise standards, escalation paths, and functional best practices
• Own quality engineering workstreams for prototype, pilot, clinical, and early production builds, ensuring compliance with design controls, supplier controls, and quality system requirements
• Define and implement inspection, test, incoming quality, and supplier release strategies for development and clinical stage builds
• Establish and maintain control plans, procedures, work instructions, inspection plans, supplier quality plans, and acceptance criteria to support evolving pilot line and supplier processes
• Ensure builds meet DHF/DHR requirements, including inspection readiness, traceability, lot release, supplier documentation, and quality records required for clinical use
• Lead in-process, incoming, and supplier inspection strategies, including test method development, validation, measurement system analysis, and component release readiness
• Drive root cause investigation, non-conformance disposition, supplier quality issue resolution, and corrective actions across development builds, pilot operations, and supplied components
• Partner with suppliers, R&D, Manufacturing Engineering, Operations, and Quality functions to ensure designs, supplied components, and manufacturing processes are manufacturable, inspectable, scalable, and compliant
• Perform data analysis and trending to inform design decisions, supplier performance, process improvements, and risk mitigation
• Support risk management activities, including DFMEA, PFMEA, supplier risk assessments, and control strategies aligned to product and process maturity
• Support validation of pilot line equipment, supplier processes, inspection methods, and manufacturing processes with alignment to future production readiness
• Define and execute Operations Quality strategy for transition from pilot manufacturing and supplier readiness into commercial production
• Train and guide cross-functional teams while ensuring compliance with FDA, ISO 13485, supplier quality, and GMP requirements

Key Decision Rights:

• Ownership of the Operations Quality strategy spanning Manufacturing Quality and Supplier Quality support for NPI programs
• Decision-making on inspection approach, supplier quality plans, control framework, acceptance criteria, and quality readiness for pilot, clinical, and pre-production builds
• Authority to disposition non-conforming product generated during development and pilot operations, in alignment with applicable quality procedures and functional quality partners
• Escalation ownership for supplier quality issues, manufacturing quality risks, and readiness gaps impacting clinical builds or manufacturing transfer
• Input into design control deliverables, supplier readiness, verification strategies, process validation, and manufacturing transfer readiness

Required Leadership/Interpersonal Skills & Behaviors:

• People leader who can build capability, set priorities, coach team members, and create clear ownership across Manufacturing Quality and Supplier Quality activities
• Strategic thinker who can translate evolving product, process, and supplier requirements into practical, scalable quality systems
• Strong cross-functional collaborator across R&D, Manufacturing Engineering, Operations, Global Quality Engineering, Global Supplier Quality, and external suppliers
• Demonstrated ability to operate effectively in early-stage, ambiguous development and supplier readiness environments
• Data-driven and detail-oriented, with strong problem-solving, prioritization, and escalation management capability
• Ability to influence design, process, supplier, and quality decisions through functional partnership and dotted-line alignment
• Drives clarity, structure, and discipline in fast-paced pilot manufacturing, supplier development, and commercialization environments

Required Skills and Competencies:

• Experience leading Manufacturing Quality and/or Supplier Quality Engineering activities in a regulated manufacturing environment
• Expertise in inspections, incoming quality, supplier quality controls, test method validation, and measurement system analysis
• Experience with development-phase quality engineering, including design controls, DHF/DHR, supplier readiness, and clinical build support
• Working knowledge of FDA QSR (21 CFR 820), ISO 13485, GMP, and supplier quality requirements
• Experience supporting manufacturing, process development, supplier development, and early-stage production environments
• Familiarity with equipment, process, inspection method, and supplier process validation activities
• Experience working with inspection technologies, metrology, vision systems, supplier inspection methods, and incoming acceptance processes
• Strong analytical, problem-solving, people leadership, and cross-functional execution skills

Education and Experience:

• BS in Engineering or related technical discipline with 6+ years of experience in quality engineering, manufacturing quality, supplier quality, or operations quality in a regulated industry
• Prior people leadership, technical leadership, or demonstrated ability to build and lead a small cross-functional quality team
• Experience supporting NPI programs, pilot line operations, supplier readiness, and development builds required
• Medical device experience strongly preferred, particularly supporting design controls, clinical builds, supplier quality, and manufacturing transfer

Additional Information:

• Able to work in a Class 8 Cleanroom Environment as needed
• Role is based in Acton and the ideal candidate will be in office a minimum of 4 days a week
• Travel up to 10%, including international travel to equipment vendo