Senior Quality Engineer, Research and Development
29 September 2020
29 October 2020
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JOB TITLE: Senior R&D Quality Engineer
LOCATION: Pilot, Chandler's Ford, Hampshire
Work as a member of the CooperVision R&D QA department, liaising with all R&D departments across UK and US, as well as Global manufacturing and distribution sites.
Responsible for leading Concept Research Control or Design Control activities, Risk Management in the R&D and Manufacturing, ensuring that clinical trial samples, new products and new processes meet all requirements established by CooperVision procedures and appropriate regulatory requirements. Supports the maintenance and development of additional local and global quality management system elements. Supports the global quality policy and values of CooperVision.
ESSENTIAL FUNCTIONS AND ACCOUNTABILITIES
- Maintain and update global procedures for Design Control and Risk Management that adheres to, ISO 13485, ISO 14971, MDSAP and MDD/ MDR.
- Lead and review Concept Research Control or Design Control activities for clinical trial sample production, new products or process development, during all control phases, including design reviews, design, design change, design history files, and associated risk management activities.
- Develop and/or review of clinical trial sample/product/process development documentation, test method validation documentation, software/computer system validation documentation and process validation documentation.
- Support R&D in 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 support to maintain Quality System Regulation requirements including internal and external audits of Quality System.
- Support company goals and objectives, policies and procedures in compliance with quality manual and quality system processes such as CAPA system, Change Control, Management Review, Adverse Clinical Events or Customer Complaints, and Internal Audits.
- Creates a culture of quality awareness, teamwork and cooperation with all groups within the facility.
- Works closely with Regulatory Affairs, and Research and Development functional groups, to ensure compliance to applicable standards (external and internal) such as ISO, FDA-QSR and GMP.
- Participates, in Regulatory Agency Inspections of the facilities and ensures corrective actions are performed as necessary.
- Supports Manufacturing in Validation and Control Planning.
KNOWLEDGE, SKILLS AND ABILITIES
- Technically sound in quality systems and be abreast of developments in the Quality Assurance field. Including practical application of ISO 13485, ISO 14971 and FDA Quality System Regulation CFR 21 Part 820. MDSAP & MDD/ MDR is ideal.
- GMP experience mandatory. GLP, or GCP, experience ideal.
- Applied technical knowledge of Qualitative and Quantitative data analysis, and statistical tools. Six Sigma Green Belt qualified or CQE ideal.
- Project Management qualified ideal.
- Self-starter and able to work both independently and as a leader of an integrated and interdisciplinary team, carrying out assigned responsibilities.
- Excellent interpersonal and written communication skills to communicate effectively at all levels within the Quality Organisation, as well as cross functionally with departments such as R&D, Regulatory Affairs, Manufacturing, and Life Cycle Management.
- Effective coaching and mentoring skills.
- Knowledge of MS-Office and, Agile. Minitab experience ideal
- Desirable minimum 10 years related experience in the medical device field and/or training or equivalent combination of education and experience, including experience at management level.
- Bachelor in an engineering or science discipline at a minimum. Master’s degree ideal.
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