Regional QA Lead – Medical Devices

W. L. Gore & Associates; Arizona; Hybrid; USD 85,000 - 120,000; Full time

Benefits offered by this job

Stock Ownership Plan

Profit-sharing

Hybrid work arrangement

Job summary

W. L. Gore & Associates seeks a Quality Assurance Professional for the Americas Regional QA team.

You will provide commercial QA support for regional programs, collaborate with regional and global partners, and help ensure compliance with policies, standards, and regulatory requirements. Hybrid work at Flagstaff or Phoenix, AZ, with travel up to 10%. You will manage audits, CAPA, and continuous improvement and contribute to scalable QA practices supporting regional and global needs within a

Qualifications

• Bachelor’s degree (or equivalent) with 4+ years in medical device or life sciences QA, or 6+ years in lieu of degree.
• Experience supporting audits in regulated industries.
• Ability to manage multiple projects with limited supervision and meet deadlines.
• Independent quality review, guidance, and risk-based recommendations.
• Working knowledge of ISO 13485 and related regional standards.
• Experience with nonconformance investigations, CAPA, and root-cause analysis.
• Strong written and verbal communication across cross-functional teams.
• Willingness to travel up to 10%.

Responsibilities

• Support development, implementation, and execution of regional QA priorities.
• Oversee QA programs, systems, processes, and procedures for compliance.
• Collaborate with regional/global QA teams and cross-functional partners.
• Provide guidance on quality processes including investigations and CAPA.
• Maintain knowledge of regional regulatory requirements and support updates.
• Assist internal and third-party audits and closure of findings.
• Develop and improve QA procedures and change documentation.
• Monitor quality metrics and support root cause analysis and improvements.
• Build cross-functional relationships and coach others in QA practices.

Skills

Auditing

Quality systems

Risk-based decisions

Communication skills

Project management

Team collaboration

Travel readiness

Education

Bachelor’s degree or equivalent

Certified Lead Auditor ISO 13485

Job description

W. L. Gore & Associates seeks a Quality Assurance Professional for the Americas Regional QA team.

You will provide commercial QA support for regional programs, collaborate with regional and global partners, and help ensure compliance with policies, standards, and regulatory requirements. Hybrid work at Flagstaff or Phoenix, AZ, with travel up to 10%. You will manage audits, CAPA, and continuous improvement and contribute to scalable QA practices supporting regional and global needs within a