Quality Engineer

Quality Engineer focuses on supporting and facilitation of effective risk management activities at external design companies and manufacturing facilities related to assigned projects.

What the role involves

• Supporting and facilitation of effective risk management activities at external design companies and manufacturing facilities related to assigned projects.
• Ensure combination product development activities are compliant with quality and regulatory standards, both internal and external.
• Support to design validation including, but not limited to, human factors engineering assessments.
• Supporting the assessment of external design companies and suppliers for capability of quality systems, facilities, and procedures to support device development and supply.
• Supporting device design and manufacturing investigations from devices used in clinical trials and commercial manufacture.
• Supporting the generation of all regulatory submission data and content for assigned device projects.

Skills and requirements

• Or other related discipline) with a minimum of 2 years of relevant experience in the pharmaceutical combination product and/or device industries (OR).
• BSc in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering.
• History of working in accordance with the requirements of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
• Experience in design controls and risk management for combination products.

Confirmed role details

• Duration: 12 Months.
• Work Type : Onsite.
• GBP-35.00 - 35.00/ Hr.
• This position is in the Biotherapeutics Pharmaceutical Research and Development Devices Centre of Excellence located in client location.

Candidate fit

• technical judgement, safe working habits, careful diagnostics, and practical problem-solving