Quality Assurance Specialist

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 parties. Design 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).

About the Role
This role will focus on advising on quality matters within the Design & Development process focusing on the firms electronics sequencers and software.

Key Responsibilities

• Performance of quality review of processes and work instructions documents (e.g. requirements specifications design outputs drawings material specifications labelling test plans/protocols test reports) and other relevant quality records.
• Attendance in and contribution to design reviews. Contribution to risk management and production process development.
• Performance of internal audits as required.
• The post holder shall have the authority to review and approve all processes documents and records related to design and development.
• Review of design and development documents as outlined above. Performance of internal audits production and progression of non-conformities and CAPA.
• Other reasonable general quality activities required to help 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.).

Qualifications / Education
Essential

• Qualification to HND level or higher in relevant engineering (e.g. electronics or mechanical) area.

Desirable

• Experience/understanding of software development or control would be strongly desirable.
• Qualified lead auditor would be desirable.

Experience
Essential

• A minimum of 10 years experience in a design quality test or general quality function working on electronic products (either scientific or medical) working within either a certified ISO 9001 or ISO 13485 environment.
• Experience of and demonstrable understanding of the concepts relating to design control verification validation change control non-conformance preventive and corrective actions and statistical techniques are needed.
• Experience with quality assurance management with a majority of the following: to electro-mechanical assemblies PCBA design/manufacture labelling SMD processes and experience of working with research and development teams.
• Experience and demonstrable understanding of ISO 13485 (at least those sections relating to Product Realisation) ISO 14971 document control methods non-conformity and CAPA.
• Experience of monitoring performance and driving change across the QMS through the regular analysis of data.

Desirable

• Experience of the IVD or medical devices industry is advantageous but not necessary strong understanding of quality principles and demonstrable ability of putting them into practise in the design and development process is what is needed.
• Experience of supporting (from the manufacturer side) CE audits or FDA inspections is useful but not necessary.
• Deep understanding of process validation control and traceability of records and materials is strongly desired.
• Experience and understanding of firmware or software development according to IEC62304 is highly desirable.
• Experience of injection moulding and overmoulding and robotic (computer controlled) production processes is desirable.
• Understanding of process risk management (PFMEA) is desirable.

Knowledge / Skills / Abilities

• 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.

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