Design Assurance Engineer II
Fulfill the quality assurance responsibilities of product development and related PTP engineering activities.
The Role:
* Create and maintain a culture of commitment to improving patient safety, customer satisfaction, and product quality.
* Assure compliance by interpreting and fulfilling regulatory requirements applicable to the medical device industry.
* Promote and effect compliance to quality, business, and health & safety systems and market/legal regulations.
* Analyze, reduce, and manage risks associated with design, use, and manufacture of devices.
Responsibilities:
* Interface with R&D, Regulatory Affairs, Clinical, Marketing, Process Development, and Manufacturing functions in a project team environment.
* Liaise with corporate and divisional quality systems and regulatory affairs personnel to ensure compliance of product development activities.
* Monitor the release and updates of quality policies to ensure compliance with Product Development needs.
* Continually seek improvements in product and process quality.
* Implement, maintain, and update procedures to ensure R&D documentation meets Product Development Process and Design Control requirements.
Technical Expertise:
* Provide regulatory compliance, risk management, design control, and quality systems expertise.
* SUMMARIZE ANALYSIS DRAW CONCLUSION MAKE DECISION FROM TEST RESULTS OR PROCESS FINDINGS.
* Maintain compliance to all quality requirements.
* Keep up-to-date on ISO/EN/FDA/MDD and other Product Development related regulatory requirements.
Requirements:
* Level 8 Bachelor's Degree (240 credits) in STEM (Quality, Science, or relevant discipline).
* 3+ years experience in a similar role.
Skills:
* Design Assurance Engineer