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Senior R&D Quality Engineer job in Southampton

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Job Ref:  EMP376787
Employer:  Matchtech Group plc.
Industry:  Medical & Pharmaceutical
Country:  United Kingdom
County/State:  Hampshire
City:  Southampton
Post Code:  SO14
Salary:  £38,500 - £40,000/year
18/10/2016 21:31
Our client is one of the world's leading manufacturers of soft contact lenses and they currently have an exciting opportunity for a Senior R&D Quality Engineer to join their team on a permanent basis.

Experience in the medical device field and/or training or equivalent experience

The Job
Responsible for ensuring that new products and processes meet all requirements established by global guidelines and regulatory authorities.
Key responsibilities and accountabilities:
• Prepare, implement and develop global procedures for Design Control that adheres to FDA Quality System and Design Control regulations and ISO 13485 standard.
• Support and review Design Control activities for new products or process development
• Provide quality engineering leadership in design and development of medical device products to ensure that quality requirements are translated into product and process functional specifications.
• Provide technical leadership to support product transfers and launches in compliance with Design Control and other applicable procedures.
• Develop and/or review of product/process development documentation, method validation documentation, software/computer system validation documentation, and process validation documentation.
• Support the development of the inspection methodology and acceptance criteria for sampling plans, including the incoming, in-process, final, and validation sampling plans as part of the design development process.
• Provide leadership to maintain Quality System Regulation requirements including internal and external audits of Quality System.
• Works closely with Regulatory Affairs, Research and Development functional groups to ensure compliance to applicable standards (external and internal) such as ISO, FDA-QSR and GMP.
• Sets Quality and Compliance objectives and ensures that targets are achieved.
• Participates, personally or through representatives, in Regulatory Agency Inspections of the facilities and ensures corrective actions are performed as necessary.
Key Knowledge and Expertise
• Experience in the medical device field and/or training or equivalent combination of education and experience.
• Bachelor in an engineering or science discipline.
• Good technical knowledge of quality systems, and well abreast of developments in the Quality Assurance field. Including practical application of ISO 13485 and FDA Quality System Regulation CFR 21.
• GLP, GCP, or GMP experience.
• Applied technical knowledge of Qualitative and Quantitative data analysis, and statistical tools.
• Self-starter and able to work both independently and as a leader of an integrated, interdisciplinary team in carrying out assigned responsibilities.
• Excellent interpersonal and written communication skills to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing.
• Effective coaching and mentoring skills.
• Knowledge of: MS-Office, Minitab, and Agile
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