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Quality Systems Manager - Cambridgeshire

Quality
Ref: 509 Date Posted: Tuesday 21 Jun 2022
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Our client is a small family-run business that is extremely passionate about its products and services. Their focus is to drive the delivery of innovative and affordable equipment, which transforms and enriches people’s lives, bringing dignity and creating possibility. 

Insight, determination, and integrity are their core values and are held at the centre of everything they do. They pride themselves on having an open and honest approach ensuring they will never sell a product that doesn’t meet a person’s needs. 

This position is a full-time, at their purpose-built facility located in a green area on the outskirts of Cambridge. Due to its location, the office is not easily accessible by public transport, therefore ideally you will be a car owner. Onsite parking is free. 

Working hours are outside of the standard commute, Monday to Friday 7.30 am to 16.30pm. Benefits include free lunches, hot/cold drinks, and snacks alongside a competitive salary and Private medical healthcare. 

Description 

The Quality Management System Manager will provide the quality department with a strong Quality Management System control supporting all medical devices and associated accessories in the range of products. The role will actively support all relevant global subsidiaries and internal departments including Customer Care, Innovation, Product Management, Operations, Sales and Marketing to design, manufacture and support medical devices in accordance with ISO9001, ISO14001, ISO13485 and 21 CFR 820 standards/regulations. This role will also carry out internal audits and manage external audits to maintain compliance. 

Key responsibilities, duties & tasks 

  • To lead the management of the Quality Management System (QMS) document control and record retention systems. 

  • To implement and maintain QMS requirements to meet ISO9001, ISO14001, ISO13485 and 21 CFR 820. 

  • Manage and maintain training records for all QMS related documents and procedures. 

  • Lead internal audits to maintain compliance levels of the QMS. 

  • Lead external audits / inspections to maintain our external certifications. 

  • Lead and support supply chain in their critical supplier audit programme. 

  • Lead and resolve internal and external audit non-conformities to set timescales. 

  • Carry out Corrective Actions and Preventive Actions using a CAPA process. 

  • Responsible for reporting all QMS activity monthly. 

  • Represent and report for QMS activity in Management Reviews. 

  • Assist in Risk Management activities for business functions. 

  • Collaborate with internal process owners to create clear and concise procedures. 

Key goals & KPIs 

  • Ensure the Quality Management System is maintained to all relevant regulations. 

  • Ensure the Internal Audit programme is regularly reviewed, and audits are carried out to the schedule. 

  • Ensure training requirements are regularly reviewed and maintained. 

  • Ensure external audits are planned and carried out. 

  • Ensure that any non-conformities and observations from internal and external audits are satisfactorily resolved to set timescales. 

  • Ensure management reviews are carried out and documented in accordance with the schedule. 

General expectations 

  • Maintain personal and professional development to meet the changing demands of the job and participate in appropriate training activities. 

  • Undertake such other duties, training and/or hours of work as may be reasonably required and which are consistent with the general level of responsibility of this job, whether that be on-the-job training, in-house training or external training courses. 

  • Undertake health and safety duties commensurate with the post and as detailed in the Company’s Health and Safety Policy. 

  • Act as an ambassador of the Company and promote the company brand, always displaying a positive image to customers and members of the public. 

  • Live and breathe our core values – insight, determination and integrity; deliver to our mission statement and promote the Company’s long-term vision. 

  • Adhere to relevant quality and regulatory requirements at all times. 

 

Qualifications and training 

It is desirable that the postholder is: 

  • Certified Auditor to a recognised standard (preferably ISO13485 or 9001) 

Experience and knowledge 

  • Familiarity with the Medical Device industry. 

  • Strong knowledge of ISO9001, ISO14001, ISO13485 and 21 CFR 820. 

  • Current audit training and experience. 

  • At least 3 years’ experience in a similar quality management role. 

Skills and abilities 

  • Good written English to be able to create clear and concise procedures in the QMS. 

  • Ability to work effectively both individually and in a team. 

  • Good ICT skills. 

Other requirements 

  • Attention to detail, with good planning and organisational skills. 

  • Drive and enthusiasm. 

  • Positive, confident and determined approach. 

  • Continuous improvement mindset. 

Benefits 

  • Private medical healthcare cover. 

  • Training & development. 

  • Annual leave: 22 days per year, increasing by one day per full calendar year worked to a maximum of 25. 

  • Free lunches, hot/cold drinks and snacks etc. 

  • Competitive salary. 

Specialists in consultancy


At Medical Engineers we have a range of technical consulting jobs in the medical engineering industry throughout the UK. Requiring a broad range of technical and management skills and most importantly the ability to communicate effectively. Consultancy roles require candidates with unique abilities. Roles vary in length of contract depending on clients’ requirements.

Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

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