Design Assurance Leader
We are seeking a highly skilled Design Assurance Leader to lead and manage the implementation of design control processes, champion risk management initiatives, and collaborate with cross-functional teams to foster continuous improvement.
The successful candidate will have a strong background in quality engineering or design assurance within the medical device industry, with experience in implementing quality improvement processes and methodologies. They will be responsible for establishing excellent working relationships with quality, R&D, operations, regulatory, and commercial teams to ensure successful transitions from product development projects into commercial operations.
Key responsibilities include:
* Leading the implementation and governance of design control processes in compliance with quality standards
* Championing the development and maintenance of risk management files per ISO 14971
* Acting as the quality voice in design reviews to ensure Critical to Quality attributes are defined, validated, and monitored
* Implementing Design for Reliability (DfR) and Design for Manufacturability (DfM) principles in collaboration with R&D, Operations, and Supply Chain
This is a challenging and rewarding opportunity for an experienced professional looking to make a significant impact in the medical device industry. If you have a passion for quality and innovation, we encourage you to apply.
Key skills and qualifications:
* Bachelor of Science in Scientific, Technology, Engineering, Mathematics or related discipline
* 10+ years of experience in quality engineering or design assurance within the medical device industry
* 5+ years in a leadership role with demonstrated progressive responsibility overseeing quality engineering or design assurance teams
Benefits:
* Competitive base salary based on experience and qualifications
* Eligibility for 15% bonus and an annual LTI award
* Medical, dental, vision, retirement savings plans, and paid time off