Manufacturing Quality Manager (PFMEA) in Basingstoke

We are seeking a PFMEA/ Quality Lead who is responsible for ensuring robust, compliant, and risk‑based process control across all manufacturing and engineering change activities. The role leads PFMEA processes, ensures documentation meets regulatory and internal standards, collaborates with cross‑functional teams, oversees change control evidence, validates production processes, and drives continuous improvement in operational quality.

Key Responsibilities

• Lead, facilitate, and maintain PFMEA activities for new and existing manufacturing processes.
• Maintain high standards of communication with stakeholders and ensure timely delivery of PFMEA activities.
• Ensure PFMEAs comply with ISO 14971, ISO 13485, FDA 21 CFR Part 820, and internal QMS/risk‑management procedures.
• Validate process changes by reviewing evidence, guiding teams, and writing high‑quality technical reports to support change orders and support process readiness and product launch activities.
• Support development and maintenance of Control Plans, Process Flow Diagrams, and Work Instructions.
• Approve the Device Master Record revisions and ensure documentation accuracy.
• Support internal and supplier quality audits and support regulatory inspections.
• Review and implement engineering, design, and documentation changes impacting production.
• Maintain and improve QMS procedures and ensure regulatory alignment.
• Partner with Manufacturing Engineering to define and validate process controls using statistical tools (MSA, SPC, capability studies).
• Drive improvements to reduce variation and strengthen process capability.
• Contribute to root‑cause investigations, risk‑based decision‑making, and CAPA activities.
• Provide line management, coaching, and development for quality personnel in the production environment.
• Guide cross‑functional teams in gathering correct and supporting evidence for PFMEA and change orders and quality best practices.
• Coordinate with manufacturing teams to ensure quality standards are met through all stages of production.
• Perform additional reasonable duties aligned with role scope and organisational needs.

Skills & Experience Required

• Proven experience in PFMEA leadership within a regulated manufacturing environment; medical devices preferred.
• Experience in equipment and process validation, including IQ, OQ, PQ activities.
• Strong background in PFMEA methodology, Quality, Process Engineering, or Manufacturing Engineering and process risk management.
• Solid understanding of medical device regulations (ISO 13485, ISO 14971, FDA QMSR).
• Experience in conducting internal and supplier audits.
• Strong analytical and problem‑solving skills, using data and structured thinking to resolve issues.
• Ability to review engineering drawings, specifications, and process documentation.
• Proficiency in PFMEA software/tools.
• Experience with statistical methods such as MSA, SPC, and capability analysis.
• Strong facilitation, communication, and cross‑functional collaboration skills.
• Structured problem‑solving experience (8D, DMAIC, Fishbone).
• Bachelor’s degree in Engineering, Quality, or a related technical field.

Desirable Skills & Experience

• Experience within Class IIa, IIb or Class III (EU) medical devices.
• Lean Six Sigma Green Belt or higher.
• Knowledge of DFMEA and its interaction with PFMEA.

Vision RT is an Equal Opportunity / Affiliation Action employer; all qualified applicants will receive consideration for employment and development without regard to race, colour, religion, sexual orientation, gender, national origin, disability, or protected veteran status.