Hobson Prior are seeking a skilled Operations Quality Engineer to join a worldwide and innovative organisation that specialises within orthopaedic oncology.
- Participate in the development and improvement of the manufacturing processes for existing and new products.
- Actively participate in custom design review meetings to support custom implant manufacturing.
- Work closely with key stakeholders to resolve in-house and supplier quality problems using established problem-solving methodologies (Root Cause Analysis, 4D, etc).
- Review/approve product and process change control documentation and specifications on a divisional level as a reviewer of change control requests.
- Support the Validation department and conduct validation activities in relation to the Quality Operations department.
- Lead the risk management process for the site as required and create PFMEA’s for Operations activities.
- Provide monthly/quarterly reporting on progress.
- Conduct/support NC and CAPA investigation through to implementation of actions and closure.
- Review and approve regulatory standard change impact assessments.
- Review/approve nonconforming material and system documentation.
- Create and/or maintain SOPs, WI, and Quality forms.
- Support/Conduct 1st Off, in-process & Final Inspection activities where necessary.
- Ability to problem solve with an analytical and methodical mindset.
- Capable of working with cross functional teams.
- Able to partake in and give support to internal and third-party audits.
- Exceptional analytical and writing skills.
- Excellent organisational and presentation skills.
- Bachelor’s Degree in Engineering or Science fields.
- A minimum of 1-3 years’ experience in in the medical device or pharmaceutical industry.
- Understanding of regulatory requirements: ISO 13485, Quality System Regulation and Medical Device Directive.
- Knowledge and experience of quality tools such as FMEA, SPC/Process Control, Root Cause Analysis.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.