Medical Device Testing Specialist

1 week ago

Deeside, Flintshire, United Kingdom ConvaTec Full time

About the Role:

We are seeking a highly skilled Medical Device Testing Specialist to join our team at ConvaTec. As a key member of our R&D team, you will be responsible for designing, planning, and executing physical testing in support of new product development and existing product development of medical devices.

Key Responsibilities:

  • Working within a controlled ISO13485 and ISO9001 Laboratory quality system and in accordance with GLP/GMP procedures.
  • Design, plan, and execute physical testing in support of R&D and SEG activities and base business projects in accordance with applicable procedures and guidelines.
  • Involvement in the development and validation of new physical testing methods.
  • Effective organization of assigned workload; ensures the integrity of all data generated and timely/accurate provision of results to GLP standards.
  • Accurate recording and analysis of laboratory data in accordance with good documentation practices.
  • Perform detailed laboratory investigations to determine the root cause of 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.
  • Responsible for standard laboratory routines, equipment calibration, maintenance replenishment, etc.
  • Ensures lab compliance with applicable cGMP regulations and SOPs/TDs.
  • Involvement 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.

Working Conditions:

  • Working in a laboratory environment with exposure to biological agents, chemicals, and reagents.
  • Competent in the disposal of chemicals and reagents in accordance with site and environmental procedures - Training will be provided.

Travel Requirements:

There may be opportunities to attend external training courses which may involve daytime return travel or an overnight stay.

At ConvaTec, we are committed to providing a work environment that is inclusive, diverse, and rewarding. We believe that our employees are our greatest asset and are dedicated to supporting their growth and development. If you are a motivated and talented individual who is passionate about making a difference in the lives of others, we encourage you to apply for this exciting opportunity.

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