Principal R&D Quality Engineer

Southampton, England
GBP52000 per annum
Oct 18, 2016
Nov 15, 2016
Alex Langrish
Result Type
Position Type
Full Time

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, including experience at management level.
* Bachelor in an engineering or science discipline.
* Deep 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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