Quality Engineer

Job Description

Quality EngineerLocation: Coventry, CV3 2RQSalary: Negotiable DOEContract: Maternity Cover, fixed term for 12 monthQuality Engineer - Benefits: Competitive salary Contributory pension scheme Life cover Incapacity benefits Cash Back Medical Scheme Flexible working hoursAbout 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.SFMs 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 companys 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 companys QMS,Quality Engineer - Key Skills / Experience: 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 deadlinesIf you have the skills and experience, we require for this role and are looking for a new challenge please email your CV to us with a relevant cover letter, explaining why you are a good fit for this roleImportant Information:Due to the number of applications we receive, we will only contact those candidates that we want to take forward to interview; if you do not hear from us within 4 weeks, please assume that your application has been unsuccessful on this occasion.For Privacy Notice for Job Applicants please visit our website.No agencies please.

Keyskills :
ComplianceManufacturingProductionQuality ControlTroubleshoot