Quality Assurance Specialist

Job Description

The Quality Assurance (QA) Specialist is responsible for ensuring compliance with medical device regulations, quality management systems, and supplier quality requirements. This role supports internal and supplier audits, CAPA (Corrective and Preventive Action) programs, regulatory inspections, and continuous improvement initiatives. The ideal candidate will partner with internal stakeholders, suppliers, and auditors to maintain compliance with FDA, ISO 13485, MDSAP, and other applicable regulatory standards while driving quality and process improvements across the organization.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to View email address on click.appcast.io learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:

Skills and Requirements

Bachelor's degree in Engineering, Science, or a related field.

Experience working within Quality Systems in the medical device industry or another highly regulated industry.

Experience supporting internal, supplier, or quality system audits.

Strong written, verbal, and interpersonal communication skills.

Ability to manage CAPA activities, audit findings, and corrective actions through closure.

Knowledge of regulatory compliance requirements and quality management practices.

Ability to collaborate with cross-functional teams, suppliers, and external auditors.

Willingness to travel up to 10%. 3+ years of Quality Assurance experience in the medical device or a similarly regulated industry.

Formal auditor training and experience leading or supporting internal and supplier audits.

Knowledge of ISO 13485, FDA 21 CFR Part 820, and MDSAP requirements.

Six Sigma training and experience applying analytical problem-solving methodologies.

Experience preparing for and supporting external regulatory audits.

Background in supplier quality management and supply chain quality oversight.

Proven track record driving continuous improvement and quality system enhancement projects.