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Quality Engineer / Manager

Job Specification

Reporting
• Reports to Director of Quality and R&D

Regulatory
• Detailed understanding and experience of managing QMS to ISO13485:2016 and medical device development. Knowledge of medical device coatings, including bone integrating and antimicrobial coatings, desirable. Working understanding of MDD 93/42/EEC & MDR 2017/745 and relevant regulations and supporting standards. Ability to apply Quality & Regulatory principles to business products and services, whilst maintaining commercial focus.


QMS management
• Represents Company as Quality Management Representative
• Manage and host customer and notified body / regulatory audits
• Manage CAPA / Complaints system and active contribution to follow up actions
• Manage change control and procedural concessions
• Managing, drafting & approval of QMS procedures and document control.
• Manage, plan and perform Internal and Supplier audits to recognised standards e.g. ISO 13485:2016, FDA 21CFR 820.
• Ability to train personnel, visitors and contractors, including staff inductions
• Works closely with Operations Manager to support commercial products and services.
• Analysing data in support of monitoring KPIs and summarising for management reporting.
• Detailed understanding and experience of Risk Assessment & Product / Process FMEA, Control Plans and other QMS procedures.
• Some specialist plant calibration & maintenance activities and experience of appropriate gauging and calibration practices.
• Ability to develop a detailed working knowledge of the business processes, products and services to ensure quality measures are appropriate and improved where required.
• Champion continual improvement of QMS aligned with business, economic and commercial objectives.


Process Validation
• Detailed understanding and experience of process validation activities. Proven ability to design and manage validation activities, including statistical basis supported by DoE design and analysis where required.
• Detailed understanding and experience of Quality statistical tools SPC, process capability, Cp/Cpk/Ppk, f-test & t-test; preferably trained in use of Minitab.

If you are interested in applying please contact:
Dr James Shawcross (james.shawcross@accentus-medical.com; 01235 828270)

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