Job Title : Senior R&D Quality Engineer (Senior Analyst, Quality Assurance)
Location : Clare
Reporting to : R&D Quality Manager
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 (Honour's Level 8) 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
This position will start out as a 18 month contract , however, there is a potential that it could turn into a permanent position based on business needs and personal performance.