Senior Quality Engineer (Medtech)

TL;DR

Senior Quality Engineer (Medtech): Ensuring the quality and reliability of bioprocessing consumables from design through production with an accent on risk assessment, compliance, and design robustness. Focus on implementing quality control processes, conducting design verification and validation, and driving corrective actions in a GMP manufacturing environment.

Location: Must be based in Smithfield, RI, US (Hybrid: 1-2 days at home).

Salary: $115,000–$135,000 annually.

Company

hirify.global provides hospitals and life science institutions with innovative products and solutions for intensive care, cardiovascular procedures, and sterile reprocessing to improve clinical results and optimize workflows.

What you will do

• Collaborate with design and engineering teams to develop quality assurance plans for new products.
• Coordinate design for manufacturability and reliability activities to ensure product robustness.
• Conduct design reviews, risk assessments, and oversee prototype testing.
• Develop and maintain quality control documentation, including verification and validation plans.
• Perform root cause analysis and implement CAPA for design-related quality issues.
• Support product launches and ensure compliance with industry standards like ISO 9001.

Requirements

• Bachelor’s degree in Science or Engineering.
• 5 years of experience in Quality or Manufacturing in a GMP environment.
• Experience with new product introduction and design development.
• Cleanroom experience required.
• Knowledge of cGMP and industry regulations.
• Proficiency in quality management software (ETQ Reliance preferred).

Nice to have

• Certified Quality Engineer or Six Sigma Black Belt certification.
• Experience with plastics manufacturing (injection molding, 3D printing).

Culture & Benefits

• Comprehensive health, dental, and vision insurance.
• 401k plan with company match.
• Paid Time Off and parental/caregiver leave.
• Wellness initiatives and health assistance resources.
• Tuition reimbursement and commuter benefits.
• Short and long-term disability benefits.