| Location: Coventry | Salary: Negotiable |
| Sector: Medical Devices | Specialism: |
| Type: Permanent | Contact: Matt Henocq |
About the Company:
We are an innovative medical devices manufacturer of advanced wound care products, including combination products, from gelling fibres and fabrics. We deliver innovative, cost effective and quality products and solutions for the advanced wound care industry helping to improve patient care and wellbeing.
The role is responsible for supporting the Quality Management System and the management of supplier quality within the business. The quality engineer will work closely with the Quality Manager to develop and deliver a range of proactive and responsive QMS and Supplier Quality Assurance (SQA) initiatives.
Deliverables include:
* Ensuring the business' QMS development, effective maintenance and continued compliance to medical device regulations and standards i.e. ISO 13485, MDD/MDR, US FDA QSR, Canada CMDR and all other applicable requirements,
* Deliver the quality elements of project in collaboration with other business functions like R&D, Operations etc.,
* Lead the management of the business' supplier approval programme ensuring suppliers are approved, evaluated, and audited as per the company's internal procedures and requirements,
* Manage the delivery of the supplier audit schedule,
* Support internal audits as an internal auditor, along with management of corrective actions,
* Management of suppliers' corrective actions (SCARs),
* Support external and customer audits,
* Lead the management of product and process change control activities,
* Support the quality training programme in the company, developing into a subject matter expert,
* Work within the Regulatory Affairs and Quality function to promote continuous improvement and ensure compliance with quality policies across the business,
* Lead and manage the validation of software used in the company QMS,
* Adhere to and deliver the compliance scheme with the company regulatory, compliance and quality structure,
* Any other duties as assigned by the line manage or the business.
Key competence / skills / abilities:
* A demonstrable working knowledge and experience of applying ISO 13485, FDA 820 part 21, MDD/MDR and Canada CMDR requirements within the Medical Device industries is essential,
* Internal auditing experience is essential; supplier auditing is desired
* Working within a cleanroom manufacturing environment is desired
* Ability to influence without direct authority is essential
* Able to work with minimum supervision and as part of a team
* Strong communication skills both verbal and written, flexible attitude and capable of working under pressure to tight and constantly changing deadlines
Services advertised by Gold Group are those of an Agency and/or an Employment Business.
We will contact you within the next 14 days if you are selected for interview. For a copy of our privacy policy please visit our website.
