Senior Quality Specialist

Senior Quality Specialist
Location: Coventry, West Midlands, CV3 2RQ
Salary: Competitive, DOE
Contract: Permanent, Full time
Benefits:
• Competitive salary
• Contributory pension scheme
• Life cover
• Incapacity benefits
• Cash Back Medical Scheme
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.
About the Role:
Currently an exciting opportunity has arisen for a motivated and dynamic Senior Quality Specialist to join and support Quality Assurance team. The role is responsible for supporting the management and continued effectiveness of Quality Management System within the business. The Senior Specialist will work closely with the Quality Manager to develop and deliver a range of proactive and responsive QMS and Supplier Quality Assurance (SQA) initiatives.
Senior Quality Specialist - Duties to include:
• Lead supplier management including qualifications, performance evaluations, audits, complaints, and corrective actions (SCARs),
• Lead the management of the business product and process change control programme,
• Lead the maintenance and management of the SFM standards database, ensuring all standards are current,
• Lead the asset calibration programme,
• Support the management of the SFM training programme, ensuring training matrices and records are maintained,
• Support the management and co-ordination document control within the business via use of the electronic document control system, contributing to the drafting of documentation, managing the review, approval and distribution of documents including procedures, SOPs, WIs, and forms within the SFM QMS,
• Support the management and maintenance of the businesses integrated quality management system,
• Support the delivery and management of the business nonconformity programme,
• Support the delivery of the business’ audit programme including internal, customer, external, and supplier audits,
• Deputise for the Quality Manager as required,
• Contribute to create and maintain a proactive leadership style and compliance culture throughout the company to achieve high standards of excellence, sharing best practice,
Senior Quality Specialist - Key skills / abilities:
• Regulatory, science or engineering degree or equivalent
• Knowledge of the Medical Device Directive 93/42/EEC, Regulation EU 2017/745/EEC, USA 21 CFR 820, UKCA
• A demonstrable working knowledge and experience of applying ISO 13485, USA 21 CFR 820, EU MDR 2017/745, and Canada SOR 98.282 requirements within the Medical Devices or Pharmaceutical industries
• Dynamic and pragmatic team member and flexibility to work within the dynamics of a cross-functional team
• Strong communication skills
Desirable Additional Experience:
• ISO 13485 auditor qualification desirable
• Advanced wound care manufacturing an advantage
• Cleanroom experience an advantage
Important 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.
If you have the skills and experience we require for this role and are looking for a new challenge, please click on APPLY Today and forward an up-to-date CV and cover letter, explaining why you are a good fit for this role.
No Agencies please