Address
SalaryDate: Jan 8, 2024
Location: Dunfermline, GB, KY11 8ZS
Company: Optos
Quality Engineer
Dunfermline, Fife
Temporary – 12 months
Dunfermline, Fife
Temporary – 12 months
ROLE SUMMARY
We are currently looking for a Quality Engineer to join our Quality team on a 12-month fixed term contract, based in Dunfermline. You will be responsible for supporting Optos in delivering a safe and effective product that complies with all applicable regulatory requirements by providing Quality Assurance representation, input and oversight in the development and manufacture of devices.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Strategically lead performance improvement projects to increase the capability of consistently meeting requirements. Projects may include process analysis, value stream mapping, process capability and throughput analysis, 6-Sigma, 5S and Kaizen events.
- Lead, support, and challenge suppliers to ensure the correct quality for delivered product to Optos.
- Assist with the collation, review and presentation of product and QA metrics to enable feedback and support regulatory compliance.
- Drive compliance by supporting internal audit process and performing internal audits as required.
- Assist in the application of Optos’ risk assessment process to product development and change control.
- Perform QA review and approval of process documentation (SOP’s, WI’s, Route Cards, C of C/R’s, PQ Protocols / Reports etc.)
- Provide support during the preparation, hosting and follow up of 3rd party audits.
- Participation in project teams as Quality Assurance representative.
MINIMUM QUALIFICATIONS
- HNC/HND (or equivalent) in a related subject or equivalent education gained through work experience.
- Knowledge and practical experience of ISO 9001/13485 system is essential.
- Previous experience in a quality department or drawing office, ideally within a manufacturing environment.
- Previous documentation experience in a medium/high volume manufacturing environment.
- Proven ability and significant commercial awareness of FDA regulatory issues.
- A mind set which continually assess performances and seeks opportunities for improvement.
- Familiarity with auditing techniques.
- Flexible, persistent, and pragmatic.
- Technically driven with good analytical skills.
- Good written and verbal communication and negotiation skills.
- Strong pro-active communicator with the ability to influence others.
- Ability to produce high quality work under pressure and within tight timescales.
- Good computer skills (MS Office applications).
BENEFITS
At Optos, we offer a highly competitive compensation and benefits package.
EQUAL OPPORTUNITIES EMPLOYER
We are an equal opportunities employer and welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation, age or protected veteran status.
