Harmonics have an excellent opportunity to join a highly regarded company in the Midwest on an 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.
Responsibilities:
- Support QA Design assurance activities in R&D, Supply chain, System integration, Packaging Development and Customer Support.
- As assigned, act as quality representative on Design Change Projects and Innovation projects.
- Review design projects at each phase of the Design Control process for compliance and ensure compliant closure of Design History Files (DHFs).
- 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 problems in straightforward situations; analyses possible solutions using technical experience and judgment and precedents.
- 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.
- 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 relevant technical field with a minimum of 2 years’ experience in a highly regulated (FDA desirable) healthcare or related environment OR Master’s degree with 0-2 years’ experience in a highly regulated (FDA desirable) healthcare or related environment with a Bachelor’s degree relevant technical field
- Desirable to have previous experience in IVDDs, Design Controls and/or Risk Management.
- Excellent interpersonal/communication skills.
