Medical Device-Jobs in United States

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About Us
Oxford Nanopore Technologies (ONT) and its subsidiary Oxford Nanopore Diagnostics (OND) develop, manufacture, and sell products based on ONT’s 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, 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:

• 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.
• 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.
• 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