Quality Systems Engineer
Salary Highly Competitive, details in request
We have a vacancy for a Quality Systems Engineer (Risk Management) to join our client, a global medical devices company in Yorkshire, predominantly involved in the fields of woundcare. You will be joining the Quality Systems Department at the site in Yorkshire.
The role of Quality Systems Engineer supports all aspects of Risk Management activities to maintain compliance to ISO 14971requirements from a Franchise and Operations perspective for the introduction of new products, line extensions, project work and process/raw material changes.
- Work with R&D, Manufacturing and Quality groups in identifying hazards and associated risk associated with design & application of the product and manufacturing processes.
- Collation of data into failure mode effect analysis (FMEA) tables for identifying and accepting risks based on current controls.
- Creation of Risk Management report and justifying acceptance of data.
- Escalation process for non-conformances / customer complaints.
- Review of customer complaint data in respect to Risk Management activities.
For the Quality Systems Engineer we’re looking for a candidate with/who:
- Degree in Quality, Engineering, Science or other related subject.
- And / or substantial experience in a medical device / pharmaceutical regulated environment.
- Understands Risk Management concepts.
- Works collaboratively within and across teams, has a flexible approach to work and able to build strong relations.
- Demonstrates a sense of urgency to meet customer needs and approaches all challenges enthusiastically.
- Drives process improvements.
On this occasion, LiCa Scientific is acting as an employment agency.
Please email firstname.lastname@example.org with you CV/Covering letter.