Life Sciences Quality Specialist

24 hours ago

New Ross, Loch Garman, Ireland beBeeBiocompatibility Full time $65,000 - $123,456

Our Life Sciences team is dedicated to fostering an environment where each member's unique perspective contributes to our collective success.

We uphold the highest standards of quality, integrity, and customer satisfaction in everything we do:

  • Quality
    • We prioritize our customers' needs above all else.
    • We strive to create innovative solutions that meet their requirements.
  • Innovation
    • We foster respectful interactions among team members.
    • We maintain open and honest communication throughout the organization.
  • Collaboration
    • We ensure that every decision and action aligns with our core values.

As a Quality Engineer, you will support life sciences activities by ensuring our requirements are met or exceeded. You will learn and apply microbiological and biocompatibility concepts in medical device manufacturing.

Key Responsibilities:

  1. Adhere to our values and safety protocols, including quality management systems, U.S. FDA regulations, and company policies.
  2. Support life sciences activities independently, with occasional guidance from experienced mentors and managers.
  3. Review and apply applicable standards and procedures for sterilization, environmental monitoring, product cleanliness, and biocompatibility.
  4. Write and review protocols, reports, and other documents related to sterilization, microbiological test methods, and/or biocompatibility.
  5. Perform technical projects, following standard quality management and laboratory methodologies, to evaluate and improve the quality of medical devices.
  6. Apply data analysis practices and techniques to establish root cause for out-of-specification results and support justification for improvements.
  7. Collaborate with others in the exchange of information, ask questions, and confirm understanding with Life Science mentors to support development as a Life Science associate.
  8. Perform other duties as needed and directed by line supervision.

Working Conditions:

The working environment varies from a standard office setting to laboratory and production areas, including cleanrooms with gowning requirements and high noise levels.

Qualifications:

  • Minimum bachelor's degree in Biology, Microbiology, or related technical field.
  • At least 3 years of experience; alternative consideration for 7+ years of relevant experience without minimum education requirement.
  • Demonstrated ability to work independently and collaboratively with other associates and cross-functional teams.
  • Technical aptitude with effective communication skills in written and oral formats.
  • Maintain a calm demeanor in high-energy environments and possess a positive, can-do attitude with no tolerance for failure.

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