Validation Engineer, Medical Devices
Market leading, Sheffield based manufacturer of medical devices is currently experiencing growth and variance in its product range, bringing with it a need to devise new manufacturing processes or change existing ones. This fact, combined with more stringent controls from FDA has led our client to review its validation strategy and strengthen in these areas through the appointment of a validation engineer.
Working closely with the manufacturing, quality and compliance teams, the successful applicant will create evidence trails to show that each step of a products lifecycle, from NPD, through manufacturing, packaging and into the distribution network, leads to a consistent and reproducible result.
Duties will include:
- Support the design and planning of the site master validation schedule.
- Ensuring compliance to the applicable Medical Device Directive (MDD), ISO 13485, ISO 14971, ISO 9001 and FDA (QSR) regulations as they apply to all onsite processes.
- Maintain regular direct contact with customers, regulatory bodies and external auditors on both Quality & Environmental issues.
- Producing IQ/OQ/PQ documentation.
- Execute validation protocols for NPD and NPI. Working with the R & D team to create/maintain Technical File and DHF documentation, capturing activities in the appropriate format.
- Involved in new process development and new process/ new plant and equipment validation, setting out user requirements and SOP's.
- Retrospective product and process validation to FDA and EU regulatory standards.
- Validation of measuring equipment, including CMM's and measuring techniques such as gauge R & R's.
- Establish and maintain procedures, tools and methodologies to cover sterilization and reprocessing cleaning programs.
- Working with external bodies for packaging validation of terminally sterilized products, considering all aspects of transportation and product storage.
- Applicants will have experience in some of the following areas:
- Experience gained in the writing of validation protocols and IQ/OQ/PQ documentation.
- Worked within an engineering/ manufacturing business and gained exposure to validation activities whilst working in areas such as; manufacturing engineering, compliance, quality engineering, or maintenance engineering.
- Ideally from a metals manufacturing background; experience of validating machine tools would be useful.
- Knowledge of compliance to the applicable Medical Device Directive (MDD), ISO 13485, ISO 14971, ISO 9001 and FDA (QSR) would be advantageous, however training and support will be provided where necessary.
- Experience of conducting FMEA's and Risk Analysis.
At this moment the business is expanding into new markets and new territories that requires the company to become more developed and advanced in the areas of Validation. There are many changes and improvements that will take place in this area of the business, providing an opportunity for someone within this area to take the lead.
Key words: Validation, compliance, quality, manufacturing engineer, FDA, 13485, 14971, IQ, OQ, PQ.
This job was originally posted as www.totaljobs.com/job/78319895