Remuneration: £40,000 - £50,000 Per Annum
Location: Loudwater, High Wycombe
BJD Group are excited to be recruiting for a varied Quality Manager position. You will be responsible for maintaining the organisations Quality Management System, in respect to both ISO and FDA requirements, as well as ensuring compliance with national and international requirements.
As a Quality Manager your responsibilities will be to:
- Understand and ensure compliance with the quality system and be aware of the impact the position has on both the customer and quality
- Manage aspects of the quality management system and support documentation and processes
- Report on the performance of the quality management system and any need for improvement
- Coordinate, evaluate and sign off on CAPAs, quality plans, documentation, customer complaints, audits, validations, training, and other quality feedback mechanisms
- Maintain an in-depth understanding of the quality and documentation systems, applicable standards and requirements
- Monitor process controls associated with all business functions to ensure compliance with the requirements and intent of the established ISO quality system
- Ensure that all personnel follow operating procedures and work instructions relating to their assigned responsibilities
- Consult on process improvement issues and leading cross-functional improvement teams
- Maintain an awareness of Regulatory Affairs as it relates to and impacts Key Surgical and including the requirements for vigilance reporting
- Ensure the promotion of awareness of customer requirements throughout the organisation
- Ensure that positive customer feedback is shared and that all constructive customer and agency feedback, including complaints, are properly documented and reported to Management
- Conduct and approve audits: internal, external, and supplier
- Conduct quality system training for company personnel as required to comply with quality system requirements
- Review product documentation and records, including quality control test results, as needed (e.g., sterilisation certificates, sterilisation validations, routine dose audits, certificates of conformance) for the release of product
- Recognise and handle product, process and quality system non-conformities
- Perform other related tasks as assigned and required
- Act as the ISO Management Representative.
- Coordinate, evaluate and sign off on all NCMRs, quality plans, documentation, customer complaints, audits, labelling, validations, training and other quality feedback mechanisms
- Supervise personnel by providing direction, feedback, and performance reviews
- Oversee that the quality of purchased products and raw materials is sufficient to meet customer requirements.
- Oversee the operation of incoming product assessment and to ensure that all test procedures are in-place and that test equipment is suitably calibrated
- Oversee Goods In and QC activities.
We are looking for an experienced & flexible Quality Manager who has excellent understanding of ISO 13485 as well as knowledge of working under the Medicine and Healthcare products Regulatory Agency. The successful candidate will also have:
- Science-based and/or quality-based background
- At least 5 years experience in quality with minimum 2 years in a leadership role (manager, supervisor or lead capacity)
- Prior work experience within a highly regulated environment such as medical device, medical supply or pharmaceutical is required.
- Must have foundational knowledge and experience working with quality management systems and the ability to develop and improve quality management systems (experience with ISO 13485 is preferred).
- Ability to resolve technical and quality problems.
- Proficient in MS Word, Excel and Outlook
- Supervisor/Management experience strongly preferred
- Solid communication, decision-making and organisation skills
- Ability to delegate and negotiate
- Ability to handle stress and manage conflict
- Ability to manage multiple projects with overlapping timelines
- Understand all aspects of a project and determine the impact they might have on other projects, areas or processes prior to implementation
Package and Prospects
On offer is a salary between £40,000 - £50,000 Per Annum for the right candidate. Join a friendly, diverse team where people value excellence, team spirit, passion, pragmatism and accountability.
If you are interested in this role, click 'apply now' to send us an up-to-date copy of your CV.
BJD Group are the UK's leading management recruitment experts within the logistics and supply chain sector. Since 1991 we have worked with clients and candidates to provide a professional, trusted service from initial engagement to securing your next role and beyond. Please visit our website at bjdgroup.co.uk for the latest logistics and supply chain vacancies.
BJD Group acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. By applying for this position I understand that my details will be processed in accordance with BJD Group's Data Retention Policy which can be accessed at bjdgroup.co.uk