Manufacturing Quality Manager
Manufacturing Quality Manager
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Job Description
About Us
Oxford Nanopore Technologies (ONT) and its subsidiary Oxford Nanopore Diagnostics (OND) develop manufacture and sell products based on ONTs unique and market-leading nanopore-based next-generation gene-sequencing (NGS) technology. Our products support both research use and IVD applications and we also collaborate with a wide range of third parties for assay development. With design and manufacturing based in Oxford and global marketing our IVD instruments and assays are subject to international regulations. OND and ONT operate two Quality Management Systems: ISO 13485 (OND) and ISO 9001 (ONT).
The Role
As part of our expanding quality function were 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. Youll 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 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
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Required Experience:
Manager
Employment Type
Full-Time
