Pharmavise Corporation
Excellence through Quality: Pharmavise, your strategic Life Sciences, Healthcare, and Government solutions partner.
Quality Engineer
Location
United States
Posted
141 days ago
Salary
Not specified
Bachelor Degree5 yrs expEnglish
Job Description
• Ensure compliance with medical device regulations
• Drive quality excellence across the product lifecycle
• Collaborate with R&D, Manufacturing, Regulatory, and Supplier Quality teams
• Support design control activities and risk management
• Conduct root cause investigations and manage CAPA processes
• Support internal, external, and regulatory audits
Job Requirements
- 5+ years of experience in medical device quality engineering
- Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, or a related scientific discipline
- Knowledge of FDA QSR, ISO 13485, and ISO 14971
- Hands-on experience in process validation, CAPA, risk management, and audit support
- Familiarity with statistical analysis tools and data-driven decision-making
- Certification in Lean Six Sigma, ASQ CQE, or a similar credential preferred
Benefits
- Health insurance
- Paid time off
- Professional development
- Remote work options
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