Beckman Coulter Diagnostics

Senior R&D Quality Engineer 18 month FTC (BB-8C4F8)

Found in: Neuvoo AU

Description:

Job Title: Senior R&D Quality Engineer (Senior Analyst, Quality Assurance)

Level: P3

Location: Clare

Reporting to: R&D Quality Manager

Responsibilities:

  • As assigned, act as quality representative on Design Change Projects and Innovation DP projects.
  • Review design projects at each phase of the Design Control process for compliance and ensure compliant closure of Design History Files (DHFs).
  • Support R&D, System integration, Packaging Development and Customer Support from a QA perspective.
  • Responsible for the support of the Design Control Process, including design change, within all areas in BCII.
  • Review and approve validation protocols (equipment, utilities, processes, cleaning, test methods and software) and final validation reports ensuring compliance to all applicable procedures, work instructions and standards.
  • Solves complex problems and exercises judgement on the analysis of multiple sources of information.
  • Aid in updating all Design Control and R&D procedures/systems, as well as above mentioned departments, to ensure compliance with regulations and BC global procedures.
  • Acts as a resource for colleagues with less experience and provides training to staff on the specific requirements of the Design Control process in BCII and regulatory or standard requirements.
  • As required conduct internal audits to ensure compliance of R&D and other technical areas as appropriate (System Integration, Packaging Development and Customer Support) with ISO13485 and FDA quality requirements.
  • May act as a Risk Management Specialist.
  • May act as a FMEA facilitator.
  • Completion of Post Market Surveillance reports.
  • Other duties as prescribed by the BCII R&D Quality Manager or Senior R&D Quality Manager.
  • Education & Experience:

  • Bachelor’s degree in chemistry, biochemistry, biology or other relevant technical field with a minimum of 5 years’ experience in a highly regulated (FDA desirable) healthcare or related environment OR Master’s degree with a minimum of 3 years’ experience in a highly regulated (FDA desirable) healthcare or related environment with a Bachelor’s degree in chemistry, biochemistry, biology or other relevant technical field OR Doctoral degree with 0-2 years’ experience in a highly regulated (FDA desirable) healthcare or related environment with a Bachelor’s degree in chemistry, biochemistry, biology or other relevant technical field.
  • Desirable to have previous experience in IVDDs, Design Controls and/or Risk Management.
  • Excellent interpersonal/communication skills.
  • Strong team member with the ability to identify and drive quality improvements.
  • Excellent planning and organisational skills
  • calendar_today3 days ago

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