Quality Assurance Engineer: IV

About the Role

Key Responsibilities

• Serve as the primary QA reviewer and approver for design documentation (requirements, risk assessments, test plans, CAPA).
• Lead activities related to design control, change control, and risk management.
• Provide hands-on mentorship to software engineers and cross-functional team members.
• Maintain Design History Files (DHF) and ensure compliance with FDA QSR, ISO 13485, IVDR, and MDSAP.
• Support internal audits and external inspections.
• Utilize Helix ALM for requirement and test traceability.

Requirements

• 10-15 years of Quality Assurance experience in medical device or diagnostics.
• Extensive experience with design control, risk management, and regulatory compliance.
• Comfortable reviewing and approving documentation independently.
• Confident mentoring R D and software development teams on quality standards.
• Familiarity with FDA QSR, ISO 13485, MDSAP, IVDR.
• Proficiency with Helix ALM or comparable traceability tools.

Nice to Have

• QA experience supporting regulated software development.
• Agile development exposure.
• Certifications such as CQE, CSQE, CQA, or Six Sigma Black Belt.

Qualifications

• Not explicitly specified, but implied: extensive QA experience in regulated environments, familiarity with medical device regulations.

Benefits & Perks

• Medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits, and a 401K plan.
• Paid leave including Paid Sick Leave or any other paid leave required by law.
• Holiday pay where applicable.