Job Ref: 214463226

Date: 2021-08-18 14:30:46

Apply Now

SRG partner with an established group off Medical Device companies encompassing managed equipment services and device implementation across a range of therapy areas.

Due to continual growth, a Quality Assurance Manager is required to oversee, and manage all aspects of their QMS system, with a key focus on QA/RA requirements across each business unit. You will be a key member of the senior management team, reporting directly to the CFO.

Key Responsibilities:
* Liaise with various Heads of Departments, internal and external stakeholders with reference to quality assurance and regulatory affairs
* Responsible for all audits and inspections
* Managing the recently implemented electronic quality management system
* Responsible for two staff members, a Quality Officer and a part time QA Admin
* Lead regular management review meetings for each company, collating and analysing relevant data
* Advising on Quality strategy for the various businesses
* Maintain commercial and contractual awareness to ensure compliance to contractual obligations
* Be responsible for change management across the business
* Look for opportunities for improvement across the companies
* Ensure compliance to ISO 9001:2015 and ISO 13485:2016
* Implement ISO 17025:2017, standard for testing and calibration laboratories with respect to the calibration of test equipment and obtain certification through UKAS
* Work towards combining the quality management systems of all three business units Manage the internal audit schedules of the three companies
* Supplier management
* Document management
* Perform internal and supplier audits (these are mainly performed by the Quality Officer and other trained internal auditor)
* Manage non-conformances, device incidents, Field Safety Notices and complaints
* Manage the health and safety coordinator and review H&S processes and records
* Writing quality management system related responses for tender bids
* Risk management
* Manage GDPR issues committee
* Member of Health and Safety Committee
* Oversee training record management for all employees
* Ensure regulatory compliance for all imported products and that all requirements as a distributor of medical devices are fulfilled

Experience/Skills
* Excellent understanding of ISO 9001:2015, thorough knowledge of quality management systems.
* Demonstrable experience in managing the Quality function of a business
* Requires excellent communication skills
* Must demonstrate supervisory and/or management experience in a similar role
* Must be an experienced auditor
* Experience required in a highly regulated industry, experience in the field of medical devices would be advantageous but not essential
* Experience of ISO 17025:2017 would be advantageous
* Understanding of ISO 13485:2016 would be advantageous
* Should be experienced in dealing with the MHRA

Benefits:
* An optional company car is part of the package
* 28 days holiday
* Pension scheme
* Private healthcare with Vitality
* Free on-site parking

This is a permanent full time role, based in the head office in High Wycombe 3 days per week, with some home working. You must be willing to travel to sites, mainly in London, with very occasional travel to sites in Greater Manchester and Southampton

Apply Now