What are the responsibilities and job description for the Design Quality Engineer II position at BioTalent?
Key Responsibilities
- Design and Development Support:
- Act as the primary quality representative during design and development activities.
- Ensure compliance with applicable standards, including ISO 13485, FDA 21 CFR Part 820, and EU MDR.
- Participate in risk management activities, including conducting and reviewing DFMEA/PFMEA.
- Regulatory Compliance:
- Ensure adherence to Design Controls, including documentation of Design History Files.
- Support regulatory submissions by providing necessary quality documentation.
- Interpret and apply relevant global standards and regulations to product design.
- Verification and Validation (V&V):
- Develop and execute test plans and protocols for design verification and validation.
- Review and approve V&V documentation to ensure product meets design specifications.
- Quality Assurance:
- Lead or support root cause analysis and corrective/preventive actions (CAPA) for design-related issues.
- Review and approve engineering change orders (ECOs) and design changes.
- Collaborate on supplier quality management as it relates to design inputs and outputs.
- Continuous Improvement:
- Promote quality best practices within the engineering and product development teams.
- Identify and implement process improvements to enhance product quality and efficiency.
Qualifications
Education:
- Bachelors Degree in a relevant field - ideally BSME (Mechanical, Biomedical, Electrical are all acceptable).
- Advanced degree or certification (CQE, CRE, or equivalent) is a plus.
Experience:
- 3-5 years of experience in quality engineering within the medical device industry.
- Strong understanding of design controls and regulatory requirements (ISO 13485, FDA 21 CFR Part 820, EU MDR).
- Experience with risk management standards (ISO 14971) and validation methodologies.
Salary : $125,000 - $140,000
