Quality Engineer

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October 23

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Pharmavise Corporation

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Pharmavise Corporation is the first Continuous Compliance Organization (CCO) dedicated to maintaining the highest standards of quality and regulatory compliance in the life sciences industry. Our esteemed client base includes Fortune 500 companies in pharmaceuticals, medical devices, and biotechnology. We offer bespoke solutions tailored to meet the specific compliance needs of our clients, supporting them from development through commercialization and ensuring they exceed their compliance goals while enhancing patient health and safety.

11 - 50 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 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

🎯 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