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Job summary
A medical device manufacturer in Scotland is looking for a Quality Assurance professional. You will be responsible for operational quality compliance, supporting the manufacturing team, and ensuring product release processes. The ideal candidate has a relevant ONC or higher qualification and experience in a manufacturing or medical environment. Strong communication and documentation control skills are essential.
Benefits
Qualifications
- Previous experience in a manufacturing or medical environment.
- Experience of GMP in a technology company.
- Hands on background in systems manufacturing and test.
Responsibilities
- Support the production department by reviewing, approving, and releasing manufactured systems.
- Conduct goods in inspection of components and provide approval.
- Monitor supplier performance and participate in MRB reviews.
Skills
Education
ROLE SUMMARY: Reporting to the Quality Director and responsible for operational quality compliance including product release. Working day to day as part of the Operations and Manufacturing team, overseen by the Manufacturing Supervisor.
- Work with the Supplier Quality Engineering Team in executing a plan to support the Optos product range.
- Support the Optos Plc production department by reviewing, approving and releasing all manufactured systems and modules.
- Provide goods in inspection of bought in parts from suppliers, providing approval and release of parts for use in production.
- Support a program for system and module reliability as appropriate to the company objectives.
- Support system and module change programs as required that have been approved by the CRB team.
- Use the NCP data in developing a quality reporting system for measuring the performance of suppliers.
- Support validation protocols as necessary in-line with ECO changes.
- Review and release all products produced by the production team such as scan heads and modules or sub-assemblies.
- Carry out goods in inspection of key components prior to use by the production department.
- Assist in providing production data on component suppliers regarding yield and material reject issues.
- Support root cause analysis of component issues.
- Support process changes with production group.
- Monitor supplier performance and take part in MRB reviews.
- ONC or higher in a relevant discipline.
- Previous experience in a manufacturing or medical environment.
- Experience of GMP in a technology company.
- Hands on background in systems manufacturing and test.
- Experience of FMEA, problem solving and SPC is beneficial.
- A background in parts and system inspection/ release within a medical device manufacturing company.
- Good communicator with all levels of staff.
- Ability to identify potential problems and take appropriate action.
- Working with production & engineering teams.
- Strong documentation control experience.
- Good written and verbal communication skills.
- Readily able to use GMP in a manufacturing/medical environment.
- Good PC skills (MS Office applications).
At Optos, we offer a highly competitive compensation and benefits package.
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.
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