Project Manager overseeing development and QA teams at Stefanini, ensuring deliverables and quality in projects.
About the role
- Design Quality Engineer ensuring quality excellence throughout design and development lifecycle of medical devices. Collaborating with cross-functional teams to resolve quality issues and ensure compliance.
Responsibilities
- Participate in creation, review and approval of medical device design and development files
- Develop and maintain risk management files throughout the product lifecycle
- Work closely with Research and Development, Regulatory, Medical Affairs and Quality Operations teams
- Identify opportunities for continuous improvement, and lead activities to implement improvements
- Support all company initiatives identified by leadership and be accountable for on-time completion of training, tasks, projects, and quality plans
Requirements
- Bachelor’s degree in engineering or related field preferred
- Preferred Certifications: ASQ CQE
- 2+ years of experience preferred
- Knowledge of medical device design and development, risk management processes
- Statistical analysis tools, root cause analysis, and continuous improvement
- Understanding of industry standards, guidelines, and regulations (i.e. AAMI & ANSI standards, GMP, 21CFR820, ISO14971, IEC62366, ISO 13485)
- Strong attention to details, organizational, problem-solving, and technical writing skills
- Confident communicator and ability to collaborate cross-functionally
Benefits
- Medical, dental and vision coverage
- Paid time off plan
- Health savings account (HSA)
- 401k savings plan
- Access to wages before pay day with myFlexPay
- Flexible spending accounts (FSAs)
- Short- and long-term disability coverage
- Work-Life resources
- Paid parental leave
- Healthy lifestyle programs
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