Senior Quality Engineer - R&D

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I am representing a global medical device company based in Hampshire who are seeking a Senior Quality Engineer operate in their R&D department where you will be responsible for Design Control and Risk Management activities.

You will need to be a qualified Engineer or Scientist and have working experience in that field and be technically sound with Quality Management Systems in a highly regulated industry. Ideally this will be in Medical Devices but the likes of Aerospace, Automotive, Pharmaceuticals or Food industries will also be considered but an understanding of GMP is a necessity.

You will be reporting into the Quality Assurance Director who pride themselves on their close coaching relationships with their team and will invest heavily in those who are properly motivated to learn and succeed in an R&D Quality role.

Key Responsibilities:

* Maintain and update global procedures for Design Control and Risk Management that adheres to FDA CFR21 Part 820, ISO 13485, and ISO 14971.

* Lead and review Concept Research Control or Design Control activities for clinical trial sample production, new products or process development and during all control phases

* 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.

* Supports Manufacturing in Validation and Controlling Planning.

Key knowledge and experience required:

* Technically sound in quality systems including the practical application of 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, Manufacturing, and Life Cycle Management.

* Effective coaching and mentoring skills.

* Knowledge of: MS-Office, Minitab, and Agile.

If this could be of interest, please apply now!

Sthree UK is acting as an Employment Agency in relation to this vacancy.