Manufacturing Quality Assurance Engineer

at  Osler Diagnostics

Job Title: Quality Assurance Engineer (Manufacturing)
Employment Status: Full Time, Permanent
Practice: Quality Assurance
Location: Oxford
Salary: Competitive

BENEFITS:

We offer a competitive benefits package, with a focus on health and well-being - further supporting the belief in our mission to enable anyone, anywhere, to access, understand and act on their health.

• 25 days holiday + bank holidays and a Christmas closure
• Annual Learning & Development budget 4% of your salary
• 12 days of Learning leave
• 4% matched pension
• £500 Well-being allowance
• Private Medical Insurance - (includes subsidised gym memberships)
• 24/7 access to a GP
• Life Assurance - x4 annual salary
• Income Protection - 75% of your basic annual salary
• Private Travel Insurance
• Annual eye tests
• Cycle to work scheme
• Travel to work loan scheme
• Relocation assistance
• Volunteering leave
• Give as you earn - pre-tax salary donations to any UK charitable organisation
• Quarterly Team Building events and social events
• Enhanced maternity/paternity

There is no perfect candidate, and no single person can do it all, but if this sounds like you, or what you could be and you’re looking for somewhere to thrive; we want to hear from you.
We look forward to receiving your application. If you have any questions, please contact talent@oslerdiagnostics.co

ABOUT THE ROLE:

We are now recruiting for a QA Engineer position based in Oxford to support our Quality Assurance Practice. In this role, you will work collaboratively with the product development and manufacturing teams to provide quality assurance in the design and development and production of medical devices.

THE ROLE

The Manufacturing Quality Assurance Engineer (MQE) is responsible for ensuring the quality and safety of products produced through the production/manufacturing processes. The MQE will be required to perform quality assurance inspections, sampling, and reviews, as well as document and report results.
The MQE will establish and maintain effective working relationships with all personnel involved in manufacturing processes and assist in the development, implementation, and maintenance of the quality assurance procedures and standards. They will act as the QA Subject Matter Expert proactively contributing to improvement work groups providing expert guidance and input into process development activity streams as well as the standardisation and systemisation of manufacturing practices and associated controls.

DUTIES AND RESPONSIBILITIES:

Procedural Compliance

• Identify and address gaps related to all aspects of product quality and compliance.
• Generates and releases paper GMP (Good Manufacturing Practices) batch records according to the manufacturing schedule. Verifies executed batch record information is completed and documented correctly (i.e. the components, lot numbers, expiration dates, etc.).
• Maintains accurate documentation of quality assurance activities.
• Performs “rounds” through the manufacturing areas to check compliance to GMP/GDocP
• Reviews cleaning logs and cleaning execution.
• Monitors, inspects, and samples manufacturing processes as required to ensure product safety and quality.
• Ensures compliance with all applicable regulations and standards.
• Provides guidance to personnel involved in the manufacturing process as needed.
• Performs other duties as assigned.

Material Conformance

• Support Incoming QC and Supply Chain teams to ensure all materials and products in the company meet the set quality standards.
• Performs AQL (Acceptable Quality Limit) inspections as required.
• Lead non-conformities associated to materials and release process and supporting the teams on identifying root causes of technical issues.
• Provide expert guidance to ensure release process is defined and followed.

Continuous Improvement

• Working with internal teams to improve the quality of materials and sub-assemblies for improving associated Key Process Indicators.
• Analyses data and results to identify problem areas and recommends solutions/improvements.
• Utilizes problem-solving and critical thinking skills to troubleshoot and resolve quality issues on the floor. This includes evaluation and disposition of non-conforming stock (e.g. quarantine, MRB practices and principles).

Process Development

• Be responsible for providing quality assurance input to the creation and approval of inspection plan, test report and documentation requirements.
• Assists in the development of quality assurance processes and procedures.
• Verifies critical steps in the manufacturing process, including but not limited to, component lot numbers/expiration dates, weight/volume, mixing, etc.
• Maintains a safe and clean work environment and champions safe working practices at all times. Challenges/reports unsafe working practices when observed.

Knowledge and Skills:

Essential

• Bachelor’s degree, preferably in a medical/scientific field or extensive on hands experience within the medical industry.
• Comprehensive experience in production quality assurance of IVD or medical device products.
• Working knowledge of the application of FDA Quality System Regulation, 21CFR 820, ISO 13485 Quality system standards for medical device.
• Experience of writing, reviewing and approving inspection plans, reports, batch release processes.
• Experience in root cause investigation/analysis (Nonconformance/CAPA process)
• Excellent attention to detail.
• Excellent interpersonal skills: ability to communicate effectively (orally and in writing) with all levels of management.
• Excellent organization, prioritization Skills and the ability to multitask.

Desirable

• Experience working with multidisciplinary development teams.
• Experience in preparing for regulatory submissions for UK, EU and US markets.
• Experience in a start-up or small business environment.
• Qualified auditor to BSI standard (or equivalent).
• Experience in Six Sigma methodology or equivalent
• Experience in participating in and supporting regulatory audits.
• Proficient in Microsoft Office Skills-Excel, Word, PowerPoint, Outlook.