About the Role

We are looking for a Quality Assurance Professional to join our Americas Regional Quality Assurance team. In this role, you will provide commercial quality assurance support and oversight for regional quality programs, systems, processes, and procedures that enable compliance with applicable policies, standards, and regional regulatory requirements. You will collaborate with regional and global quality partners, business functions including but not limited to Distribution and Logistics, Sales Operations, Training, Regulatory, Marketing, and third-party partners to support risk-based decision making, audit readiness, issue resolution, and continuous improvement. This role offers the opportunity to apply advanced quality knowledge, manage projects or processes with limited supervision, and contribute to compliant, scalable quality practices that support regional and global business needs. 

This position will be located at our facility in Flagstaff or Phoenix, Arizona, with the possibility of a hybrid work arrangement.

Responsibilities

• Support the development, implementation, and execution of regional quality assurance priorities aligned with Gore Medical quality functional priorities and business needs.
• Provide quality assurance oversight for regional quality programs, systems, processes, and procedures to help ensure compliance with applicable policies, established standards, and regional regulatory requirements.
• Collaborate with regional and global quality teams, third-party partners, and cross-functional stakeholders to maintain a balanced perspective on compliance, risk, and improvement priorities.
• Provide quality guidance and independent review for day-to-day quality processes, including nonconformance investigations, corrective and preventive actions, and risk-based decision making.
• Maintain working knowledge of applicable regional regulatory requirements and support certification maintenance, regulatory gap assessments, and implementation of regulatory updates.
• Support and perform internal, and third-party audits and assessments (i.e. distributor, supplier), including preparation, execution support, response development, and follow-up to ensure effective closure of findings.
• Develop, sustain, and improve quality management system procedures and change documentation in support of compliant and scalable regional and global processes.
• Monitor quality metrics, prepare quality reports, and use data to identify trends, escalate issues, and support timely root cause analysis and continuous improvement.
• Build strong cross-functional relationships and coach or guide others in quality practices while involving appropriate stakeholders in communications and decision making.
• Maintain compliance with training expectations as required for this position.

Required Qualifications

• Bachelor’s degree (or equivalent) with a minimum of 4 years of medical device or life sciences quality assurance experience developing, implementing, or maintaining quality systems; OR a minimum of 6 years of medical device quality assurance experience in lieu of a degree.
• Experience supporting internal or external audits in a regulated industry.
• Demonstrated ability to manage multiple projects or processes with limited supervision, effectively prioritize competing demands, and meet deadlines.
• Demonstrated track record providing independent quality review, guidance, and risk-based recommendations.
• Working knowledge of ISO 13485 and ability to learn and apply applicable regional standards and regulations.
• Experience supporting nonconformance investigations, corrective and preventive actions, root cause analysis, or other quality issue resolution processes.
• Strong technical capability with the ability to analyze difficult and sometimes complex quality or compliance issues.
• Strong verbal and written communication skills with the ability to explain quality policies, practices, and requirements to others.
• Effective interpersonal and collaboration skills with the ability to work across functions, contribute within a diverse team, adapt to changing priorities, and meet deadlines.
• Ability to travel up to 10%.

Desired Qualifications

• Quality assurance experience supporting distribution, logistics, customer service, supplier control, or other commercial quality processes.
• Experience performing quality system audits, including preparation, execution, response development, and follow-up.
• Certified Lead Auditor for ISO 13485 or equivalent quality management system standard.

This position offers a hybrid work arrangement in the country from which the Associate is employed.  Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore’s work arrangement policies.