Manufacturing Quality Manager

The Role

As part of our expanding quality function, we’re establishing a dedicated QA and QC team focused on our four production sites in Abingdon and Harwell. This role manages both QA (2 heads) and QC (1 Lead and 2 heads), reporting directly to the Senior Director of Quality Assurance. You’ll be responsible for supporting overall Production/Operations Quality Management across resources, facilities, environmental conditions, process control, validation, material specifications, inspections, internal/external audits, CAPA, change control, and certificate of conformance activities.

You will also:

• Provide primary support to the Senior Director of QA in managing and executing the QMS.
• Develop deep relationships with production functions and foster a strong quality culture.
• Review and approve all production-related processes, documents, and records.

Key Responsibilities

• Manage all QA and QC functions across UK direct manufacturing sites.
• Act as senior deputy to the Senior Director of QA, representing them in Production-related matters.
• Support the Production QA & QC team in achieving objectives and maintaining ISO 9001 & 13485 accreditation.
• Establish strong relationships with manufacturing teams.
• Support or lead internal and external audits (regulatory, customer, certification).
• Perform any other reasonable duties as required.

PERSON SPECIFICATION

Essential Qualifications & Experience

• HND or higher in a relevant science or engineering discipline (e.g., electronics or mechanical).
• A minimum of 10 years’ experience managing a production quality team across electronics and cleanroom environments within ISO 9001, 13485, or similar regulated sectors (medical device, aerospace, pharma, etc.).

Experience with:

• PCB, loom/wiring manufacturing
• QC (metalwork, labelling, PCBAs, chemical supplies, etc.)
• Wet processes, injection/overmoulding
• Robotic/computer-controlled production
• Understanding of electronic/software devices, SaMD, reagents, packaging, labelling, risk/change management.
• Demonstrated team leadership (teams of >5) and performance monitoring.
• Strong grasp of quality principles in complex manufacturing settings.
• Deep knowledge of process validation, control, traceability of records/materials.

Desirable

• Lead auditor qualification (ISO 13485/IVD).
• CE audit/FDA inspection experience.
• Experience with wafer chip manufacturing.
• Understanding of process risk management (PFMEA).

Skills & Abilities

• Detailed working knowledge of ISO 9001 or ISO 13485.
• Strong external stakeholder management with a balanced risk/commercial approach.
• Excellent interpersonal and organisational skills.
• Influential communicator at senior levels.

Attitude & Requirements

• Goal-oriented, solution-focused, and adaptable in fast-paced, agile environments.
• Highly effective communicator to non-expert groups.
• Excellent written and spoken English.
• High attention to detail with risk-based prioritisation