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Quality Assurance Engineer

2 months ago

Deeside, Flintshire, United Kingdom ConvaTec Full time
About the Role

We are seeking a highly skilled Stability Scientist I to join our team at ConvaTec, a global leader in medical products and technologies. As a key member of our Quality Assurance team, you will play a critical role in ensuring the safety and efficacy of our medical devices.

Key Responsibilities
  • Design, plan, and execute physical testing in support of R&D and SEG activities, adhering to ISO13485 and ISO9001 Laboratory quality system and GLP/GMP procedures.
  • Develop and validate new physical testing methods, ensuring compliance with regulatory requirements.
  • Organize and prioritize workload, ensuring the integrity of all data generated and timely provision of results to GLP standards.
  • Record and analyze laboratory data, applying good documentation practices.
  • Investigate atypical and out-of-specification results, apply corrective and preventative actions, and author concise investigation reports.
  • Author validation protocols, reports, and technical documents for Medical Devices/Pharmaceutical products.
  • Assist in laboratory test method/procedural revisions.
  • Ensure lab compliance with applicable cGMP regulations and SOPs/TD's.
  • Participate in change control activities and associated actions.
Requirements
  • Bachelor's Degree in a relevant science-related discipline.
  • Experience in a working laboratory environment, within Medical Devices/Pharmaceutical Industry is preferred.
  • Working knowledge and understanding of compliance with FDA and European regulations relating to Quality Systems (ISO13485:2016, ISO9001:2000, FDA 21 CFR part 820) and GMP Guidelines and Regulations.
  • Good working knowledge of Microsoft Office, specifically Word and Excel.
  • A detailed understanding of common statistical analysis and experience with MiniTab is desirable.
About You
  • Have an understanding of the role of Physical Testing within the product development process for both new product development and existing product development of medical devices/pharmaceuticals.
  • Commands good physical testing and problem-solving skills and demonstrates an understanding of the steps involved in initiating and completing a variety of physical testing tasks to support key R&D projects.
  • Statically analyze data for reporting to senior physical testing staff.
  • Effectively communicate both oral and written scientific and technical data to peers and managers.
  • A thorough knowledge and understanding of the principles and concepts of compliance management, GMP/GLP and good documentation practices.
  • Competent in the production of high-quality, accurate R&D technical documentation in a timely manner.
  • A forward-thinking team-player who willingly accepts new challenges and works to tight deadlines.
  • Commands Flexibility - ability to prioritize, manage multiple tasks and react/respond positively to changes in priority and workload.
  • Accurate with excellent attention to detail.
  • Decisive thinker: ability to make decisions and recommendations using own initiative.