What are the responsibilities and job description for the Senior Quality Assurance Engineer position at 3DISC?
Qualifications:
- Bachelor's degree in Engineering or a related field (advanced degree preferred).
- 8 years of experience in engineering quality and regulatory affairs, preferably in the medical device industry.
- In-depth knowledge of design controls, risk management, and verification/validation processes.
- Experience with CAPA, remediation projects, and internal audits.
- Strong understanding of FDA regulations, CE Marking, and ISO 13485.
- Problem-solving mindset with excellent cross-functional communication skills.
Benefits:
- Salary: Competitive, based on experience.
- Benefits: Healthcare, dental, vision, 401(k) with match, paid time off, and professional development opportunities.
