Key Responsibilities:
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* Lead and/or participate in projects focused on design modifications of devices post release to market.
* Maintain device quality and compliance, reduce costs and increase yields.
* Collaborate with other teams to ensure the effective completion of all activities associated with department projects/objectives.
* Ensure effective reporting to team leads.
* Work closely with functions like production, quality, and regulatory affairs teams.
* Support/lead the delivery of CAPA or Design projects/deliverables with responsibility for investigation/root cause analysis.
* Identify and implement corrective/preventative action.
* Verify the effectiveness of CAPAs.
Required Skills and Qualifications:
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* Bachelor's degree in engineering or a related field (desired).
* Minimum 3 years' relevant experience.
* Strong project management skills.
* Interpersonal and communication skills.
* Knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
* Problem-solving skills.
* Computer skills including Microsoft Office.
Benefits:
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* High self-motivation.
* Availability to travel on company business.
Others:
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* Compliance with Cook's Code of Conduct, Quality System requirements, and Company HR policies.
* Liaise with other manufacturing facilities as required.