Senior R&D Quality Engineer

Senior R&D Quality Engineer

CooperVision

Cahndlers Ford, United Kingdom

JOB SUMMARY

Responsible for leading Concept Research Control or Design Control activities, and 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

  • Maintain and update procedures for Concept Feasibility Control, Design Control and Risk Management, ensuring that they adhere to MDSAP, MDR, FDA CFR21 Part 820, ISO 13485, and ISO 14971 regulatory requirements. If necessary, lead remediation efforts in these QMS areas;
  • Support and review Concept Feasibility Control and Design Control activities for clinical trial sample production, new products or process development, during all control phases, including design reviews, design change, design history files, and associated risk management activities, as defined in relevant QMS procedures;
  • 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 associated acceptance criteria including sampling plans, involving incoming, in-process and final inspection, plus validation, as part of the design development process;
  • Provide support to maintain Quality System Regulation requirements including Internal, Global QMS 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 systems relating to CAPA, Change Control, Management Review, Adverse Clinical Events or Customer Complaints, and Internal/Global QMS Audits;
  • Creates a culture of quality awareness, teamwork and cooperation with all groups within the facility;
  • Works closely with Regulatory Affairs, Regulatory Compliance and R&D functional groups, to ensure compliance to applicable standards (external and internal) such as MDSAP, MDR, ISO, FDA-QSR and GMP;
  • Participate, in Regulatory Agency Inspections of the facilities and ensures corrective actions are performed as necessary;
  • Support Manufacturing functions in Design Control, Risk Management, Validation and Controlling Planning as necessary;
  • Coach QA in designated Manufacturing sites that are taking on the leadership of Design Control projects, as well as ETIG in Europe and Technical Innovations Group in Puerto Rico;
  • Support other QMS sites globally, R&D in particular, as required, e.g. regarding External Audits, Design Control, Risk Management, Investigational Device Labelling and Shipping and Supplier Qualification.

POSITION QUALIFICATIONS

KNOWLEDGE, SKILLS AND ABILITIES

  • Technically sound in quality systems, and aware of future developments in the Quality Assurance field, particularly Design Control and Risk Management. Including the practical application of MDSAP, MDR, ISO 13485, ISO 14971 and FDA Quality System Regulation CFR 21 Part 820;
  • 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, interdisciplinary team in 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, Regulatory Compliance, Manufacturing, ETIG, Technical Innovations and Life Cycle Management on a globasl basis;
  • Effective coaching and mentoring skills;
  • Working lnowledge of: MS-Office, Minitab, and Agile.

WORK ENVIRONMENT

  • Office working environment;
  • Use of computer systems.

EDUCATION

  • Bachelors degree in an engineering or science discipline at a minimum. Masters degree ideal.

EXPERIENCE

  • Minimum 10 years related experience in the medical device field and/or training or equivalent combination of education and experience.

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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