QA Senior Associate - Medical Device & Combo Products

About this role

Requirements

• Applicant must have a bachelor's degree with at least 2 years of relevant experience; or a master's degree with 0+ years; or an associate's degree with 6 years; or a high school diploma with 8 years of relevant experience.
• Experience working in Quality Assurance, GMP manufacturing environment, pharmaceutical environment, laboratory, or medical device space.
• Experience supporting or reviewing investigations in a regulated environment.
• Knowledge of root cause analysis, technical problem solving, and risk-based decision-making.
• Ability to work effectively across functions and manage ambiguity with sound judgment.
• Strong communication, collaboration, and documentation skills.

Responsibilities

• Provide Quality Assurance oversight of MDCP laboratory operations, including review and approval of test records, investigations, and change controls.
• Support root cause investigations related to laboratory testing, design verification and validation, manufacturing, and device functionality.
• Support audit and inspection readiness for both internal and external audits.
• Contribute to ongoing compliance with applicable regulatory and quality system requirements including 21 CFR 820, ISO 13485, and ISO 14971.
• Review and approve device complaint investigations with a focus on technical rigor, documentation quality, and timely closure.
• Evaluate investigation content for completeness, scientific rationale, issue linkage, risk alignment, and potential CAPA relevance.
• Partner with cross-functional teams and subject matter experts to resolve complex quality issues and improve investigation effectiveness.

Benefits

• A culture that is flexible, innovative, and customer oriented.
• The opportunity to directly impact product quality and patient safety.
• Work within a complex and highly collaborative environment with cross-functional teams.
• Contribute to a science and risk-based compliant quality culture.