Manufacturing Quality Manager
Manufacturing Quality Manager
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Job Description
Job Summary
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. In addition to selling its technologies and products into research use only applications the firm also markets IVD instruments (using the same highly complex unique NGS technology). ONT also develops its own assays and reagents and directly collaborates with a wide range of third parties to support the development of assays by those and manufacturing are based in Oxford but the firms products are marketed globally (into both RUO and IVD markets). Consequently the firms IVD instruments and assays are subject to regulations in the territories in which they are sold and regulatory filings must be made to the relevant health care authorities. To ensure that products conform with relevant regulations in territories in which they are sold; OND and ONT operate two Quality Management Systems (ISO 13485-OND & ISO 9001-ONT).
As a part of the firms expansion of the quality function it now wishes to create a subteam of QA and QC staff focusing only on the firms 4 production sites (at Abingdon and Harwell). This role will manage the QA function (2 heads) and the QC function (comprising one Lead and 2 heads) reporting to this role. Consequently reporting to and directed by the Snr Dir of QA this role will be responsible for overall quality management support of all Production/Operations matters including: resource facilities environmental process control & validation material specification through to inspection/stocking production process internal audit management of external audit production of materials/reports (and development of KPIs) for Management Review non-conformance process data capture and analysis and CAPA. Change control and Certificate of Conformance activities will be shared with the rest of the Quality team.
Reporting and providing primary support to the Snr Director of QA the role of the Manufacturing Quality Manager is responsible for ensuring the firm fully complies with its quality obligations to support the management and execution of the QMS the quality team and the wider quality function.
Key Responsibilities
The postholder is responsible as directed by the Snr Dir of QA for developing deep relationships with the production functions and for consequently helping evolve a functional and enmeshed quality culture across the production sites.
The post holder shall have the authority to review and approve all processes documents and records related to production.
Duties
Duties include but are not limited to:
Acting as local manager of all QA and QC functions and activities across all UK direct (not subcontract) manufacturing sites providing support and acting as senior deputy to the Snr Dir of QA representing them (as directed) in any matter within Production.
All activities required to help ensure the Production QA & QC team to achieve their annual objectives and maintain/sustain the ISO 9001 & 13485 accreditation.
Establish strong working relationships across the manufacturing teams.
To support (and as required lead) all internal and external audits (customer regulatory certification etc.).
Any other reasonable duties as required.
Qualifications/ Education
Essential
Qualification to HND level or higher in relevant science or engineering (e.g. electronics or mechanical) area .
Qualified lead auditor - desirable.
Experience
Essential
A minimum of 10 years experience managing a production quality team covering both electronics and cleanroom processes in either an ISOor equivalent environment (medical device aerospace defence pharma or automotive).
Experience with quality assurance management with a majority of the following: PCB manufacture loom/wiring manufacture QC (of metalwork labelling PCBAs subassemblies and chemical supplies) wet processes injection moulding and overmoulding and robotic (computer controlled) production processes.
Experience with and leading to demonstrable understanding of electronic devices software devices (which may or may not include SaMD) software assays chemical reagents packaging manufacturing labelling design and development risk management and change management.
Experience of team management and leadership of teams >5.
Experience of monitoring performance and driving change across the QMS through the regular analysis of data.
Desirable
Experience of the IVDdevices industry is advantageous but not necessary strong understanding of quality principles and demonstrable ability of putting them into practise in a complex manufacturing environment is what is needed.
Experience of leading (from the manufacturer side) CE audits FDA inspections is useful but not necessary.
Deep understanding of process validation control and traceability of records and materials is strongly desired.
Experience with wafer chip manufacturing is useful but not necessary.
Understanding of process risk management (PFMEA) is desirable.
Knowledge/Skills/Abilities/Behaviours
Detailed working knowledge of an ISOxxxx production standard (e.g. 9001 or 13485) is essential.
Demonstrable experience of working with external partners and stakeholders showing a balanced level of discretion and sensitivity to both risk and commercial interests is strongly desired.
Excellent interpersonal and organisational skills with ability to influence at a senior level. Able to form and maintain good relationships both internally and externally.
Attitude/Other Requirements
Positive and flexible attitude and experience of fast paced and agile environments. Must be goal-oriented and able to develop/evolve their own solutions.
Highly effective communicator to non-expert professional groups.
Excellent written and spoken English.
High level of attention to detail as well as an ability to prioritise based on risk.
Required Experience:
Manager
Employment Type
Full-Time
