We have an excellent opportunity to join a highly regarded company in the Midwest on a 18-month FTC. This company have an excellent culture onsite and are very people focused. They are in a growth phase and the new opportunities are as a result of expansion. Good flexi time policy and flexible working options.
- 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