Quality Manager
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
We are seeking an experienced and dynamic Quality Manager to spearhead our quality initiatives. The ideal candidate will be passionate about compliance, proactive in identifying solutions, and enthusiastic about fostering a culture of quality across all levels of the organization. This is a fantastic opportunity to make a tangible impact on a growing business and to champion continuous improvement.
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:
This role is responsible for supporting the company’s quality management system function. This will be achieved through leading the implementation and compliance to the SFM’s QMS.
Quality Manager - Duties to include:
• Ensure the business’ quality management system’s development, effective maintenance and continued compliance with business requirements, medical device regulations and standards (i.e. ISO 13485, MDD/MDR, US-FDA QSR, Canada-CMDR,), and all other applicable requirements
• Have responsibility and authority for assigned Quality management System processes, including the CAPA process, auditing, document control
• Effective line management and support of the quality management system team for SFM
• Lead coordination of internal and external quality and compliance audits and act as the primary front room lead interfacing with auditors, providing clarity to the Quality Management System (QMS) during internal, customer and regulator audits
• Provide guidance to functional team leaders during external audits
• Establish, maintain and report meaningful quality system metrics to business.
• Oversee the CAPA system and ensure appropriate CAPA strategies are in place
• Provide training relating to the quality management system to all levels of staff within the business
• Contribute to create and maintain a proactive quality culture throughout SFM and assist quality activities to achieve the standards of excellence as set out in the company’s quality policy, and share best practice where possible
Quality Manager - Key skills / abilities:
Qualifications:
• Quality, science or engineering degree or equivalent
• Member of CQI (or equivalent quality membership organisation) or working toward full membership
Competencies:
• Knowledge of the Medical Device Directives 93/42/EEC, 21 CFR 820, Regulation EU 2017/745/EEC
• Ability to gather, analyse and interpret quality information and changes in the quality environment using the appropriate quality tools
• Pragmatic team member and flexibility to work within the dynamics of a cross-functional team
• Awareness and appreciation of the need to influence in a business
• Excellent communication skills
Desirable:
• Significant experience within quality management systems in a Medical Device environment
• Able to get on with and influence people both internally and externally to achieve objectives
• Able to work with minimum supervision and as a part of a team
• Strong communication skills, flexible attitude and capable of working to tight deadlines under pressure.
Previous Experience:
• Medical device manufacturer experience
• Demonstrable experience of managing a quality management system for class 3 devices and combination products
• Experience of being the internal interface with registrar audits.
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