Medical Device Quality Assurance Specialist
4 days ago
Medical Device Quality Assurance Specialist
HireMinds partners with a leader in medical device innovation to improve healthcare through cutting-edge technology and personalized solutions.
We're seeking a Dev Quality Engineer to join the New Product Development team to ensure the quality and safety of medical devices throughout the product development lifecycle.
Key Responsibilities
- Collaborate with development teams to implement quality standards
- Lead risk management activities, including assessments and mitigation strategies
- Review and approve product/process validation activities
- Conduct design and process failure mode and effects analysis (DFMEA/PFMEA)
- Develop test methods, inspection plans, and quality control procedures
- Ensure compliance with FDA, ISO, ITAR, and other relevant standards
- Investigate non-conformances and implement corrective actions
- Support design teams in addressing quality concerns and improving manufacturability
- Assist in supplier quality management and audits
- Maintain quality documentation and contribute to regulatory submissions
Qualifications
- Bachelor's degree in engineering (biomedical, mechanical, or related field) or equivalent experience
- 3-5 years of quality engineering experience, preferably in medical devices
- Knowledge of medical device regulations (FDA 21 CFR Part 820, ISO 13485, ISO 14971)
- Experience with ITAR-covered parts development
- Proficiency in quality tools (FMEA, CAPA, statistical analysis)
- Quality certifications (e.g., ASQ Certified Quality Engineer) preferred
- Strong problem-solving, analytical, and communication skills
- Experience with additive manufacturing is a plus
Benefits
- Competitive salary ($75,000 - $100,000, based on qualifications and experience)
- Annual performance-based bonus
- Comprehensive benefits (medical, dental, vision, disability, life, 401k)
- Paid time off: Flex Time, Sick Leave, FAMLI Leave, Parental Leave, 9 holidays/year
- Educational assistance and supplemental health/life plans
HireMinds offers a collaborative, innovative environment with opportunities for professional growth in developing life-saving medical devices.
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