Quality Engineer
14 hours ago
**Quality Engineer**
**Location**: Coventry, CV3 2RQ
**Salary**: Negotiable DOE
**Contract**:Maternity Cover, fixed term for 12 month
**Quality Engineer - Benefits**:
- Competitive salary
- Contributory pension scheme
- Life cover
- Incapacity benefits
- Cash Back Medical Scheme
- Flexible working hours
**About the Company**:
SFM is an innovative Coventry-based B2B supplier of gelling fibres & fabrics for the advanced wound care industry. We offer a range of wound care technologies and all our products are manufactured in ISO certified clean rooms in line with the highest standardsof care.
SFM’s aim is to successfully deliver innovative, cost effective and quality products and solutions into the advanced wound care industry with an ultimate aim of improving patient care and wellbeing.
Currently an exciting opportunity has arisen for a motivated and dynamic Quality Engineer to join and support Regulatory Affairs and Quality team for a period of 12 months to provide maternity cover.
**Quality Engineer - About the Role**:
Key tasks and responsibilities within the role are:
- 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,
- 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’s QMS,
**Quality Engineer - Key Skills / Experience**:
- 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
**Important Information**:
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