Regulated QA

Sitka Inc.; Phoenix (AZ); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Hybrid work arrangement

Stock Ownership Plan

Total rewards program

Job summary

Gore seeks a Quality Assurance Professional to join its Gore Medical Quality Assurance team in Phoenix, Arizona. You will support day-to-day manufacturing and plant operations, including NCR, CAPA, Change Management, and other quality system processes, addressing product issues and implementing effective corrective actions.

This position offers a hybrid work arrangement in the country where the Associate is employed.

Qualifications

• Minimum 4 years of Quality Assurance experience in a regulated industry.
• Demonstrated knowledge of FDA medical device quality system regulations and ISO standards.
• Excellent written and oral communication skills.
• Ability to work independently and in cross-functional teams.
• Travel up to 5% as required.

Responsibilities

• Support day-to-day manufacturing process, CAPA and NCR investigations.
• Coordinate nonconforming product handling and CAPA processes.
• Maintain audit readiness and assist audit coordination.
• Collaborate with QA and cross-functional teams to support quality system requirements.
• Support NCR, CAPA, Change Management, FIR and process improvements.
• Guide manufacturing through quality system resolution and documentation.
• Educate others on quality system requirements and good documentation practices.
• Participate in quality system compliance audits.
• Coordinate product failure investigations to ensure timely completion.
• Enhance quality systems, including software implementation and validation.

Skills

Quality Assurance

Regulatory knowledge

Communication skills

Independence / teamwork

Travel readiness

Education

Bachelor’s degree in science or engineering

2-year degree + 2+ years medical device experience

Tools

ERP systems

PLM systems

Job description

We are looking for a Quality Assurance Professional to join the Gore Medical Quality Assurance team. In this role, you will work with cross-functional teams to support day-to-day manufacturing and plant operations, including executing the NCR, CAPA, Change Management, and other quality system processes, addressing product issues, defining and implementing effective corrective actions, and monitoring post-implementation effectiveness.

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

Responsibilities

• Support the day to day manufacturing process including problem solving, CAPA and nonconformance investigations and partner cross-functionally on appropriate risk-based decision making
• Coordinate and support execution of the nonconforming product (NCR) and corrective and preventive actions (CAPA) processes
• Ensure constant audit readiness for product lines supported and assist in audit preparation and coordination to deliver successful audit results
• Work and communicate with the quality assurance and cross functional teams as well as support organizations across the product lines and Gore Medical to support a quick and robust decision-making process in support of quality system requirements
• Support prioritized activities, including NCR, CAPA, Change Management, FIR and operational improvements
• Guide the manufacturing team through resolution of daily issues related to quality system requirements and execution of the quality system
• Train and educate others on quality system requirements and good documentation practices to ensure compliance
• Participate in and perform quality system compliance audits
• If needed, coordinate the product failure investigation process (FIR) from initiation to completion to ensure time-sensitive activities, documentation and approvals are complete
• Enhance quality systems (including software implementation and validation)

Required Qualifications

• Minimum of 4 years of Quality Assurance or other quality related experience in a medical-device, pharmaceutical, biotech or other regulated industry
• Demonstrated working knowledge of FDA medical device quality system regulations and ISO medical device industry standards
• Excellent written and oral communication skills
• Strong interpersonal and influencing skills
• Ability to work independently, as well as part of a diverse team
• Ability to set and meet aggressive timelines
• Ability to travel up to 5%

Desired Qualifications

• Bachelor’s degree in an applicable science or engineering field, OR a 2-year degree plus 2 or more years of medical device experience in a manufacturing or operations role
• Experience supporting various manufacturing processes
• Strong knowledge of ERP and PLM systems

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.

What We Offer

Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.

• We provide benefits that offer choice and flexibility and promote overall well-being.
• And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for “profit-sharing”. Learn more at gore.com/careers/benefits

Gore is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a protected veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.

Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.

Gore requires all applicants to be eligible to work within the United States. Gore generally will not sponsor visas unless otherwise noted on the position description.

For over 65 years, Gore has improved lives through discovery, product innovation and rewarding careers for Associates. We push the boundaries of what's possible - not just through our products and technologies but also through individual growth and development.

We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. Our Associates build on a rich history of innovation, upholding Gore’s values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.

Copyright 2025 W. L. Gore & Associates, Inc.