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Senior Quality Assurance Specialist

Contract Type: Permanent
Location: Midlands
Contact Name: John Reid
Contact Email: johnr@rftgroup.ie

Job Description

Senior Quality Assurance Engineer:

Due to continued expansion of their operations our client a well-established Multinational Healthcare Manufacturer now require a qualified and experienced Senior Quality Assurance Engineer.
The Senior Quality Engineer will be responsible for providing quality engineering support for all aspects of my clients incoming materials department, a dedicated resource that is responsible for developing and managing the relationship between them and their contract manufacturing partners in order to drive quality and will be responsible for managing all Quality aspects of the relationship and will partner and be a consultant and advisor to internal customers and business functions, within the company. .
This is a permanent role based in The Midlands with excellent progression opportunities
Key Responsibilities of Senior Quality Assurance Engineer:
? Ensures major nonconformance's and trends are escalated to management and prioritized commensurate with risk.
? Identifies and effectively issues SCARs where quality issues are identified in relation to product received from suppliers.
? Supports the completion of risk assessment and validations as applicable.
? Conducts device evaluations related to product issues and performance.
? Develops quality presentations, status reports and measurement processes in support of the Bought in Finished Goods business
? Communicates with stakeholders globally to ensure alignment, resolve problems, and share best practices.
? Leads major issues, when appropriate.
? Facilitates external regulatory and customer audits.
? Serve as the QA focal point for the Bought in Finished Goods relationship.
? Lead & drive programs and projects that deliver 'best in class' manufacturing metrics.
? Implement continuous improvement processes with Bought in finished Goods Suppliers in terms of product quality and service
? Change control - Review and approve supplier change requests as well as companies initiated change requests
? Monitor and control progress of supplier quality projects, ensure sound application of engineering, provide project reviews where necessary.
? Will abide to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.
? Will comply with all relevant training required and adhere to relevant associated documentation.

Requirements of the Senior Quality Assurance Engineer:
? Degree in Engineering or Science.
? 5 years' experience working in a regulated environments, specifically medical device, FDA or ISO 13485 registered work environments.
? Strong computer skills (MS Excel, PowerPoint, Word etc)
? Experience with problem solving techniques

Please send an up to date CV and cover letter to John Reid at The RFT Group / johnr@rftgroup.ie / on 01-2302400 / www.rftgroup.ie

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The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors