Regulated QA

W. L. Gore & Associates, Inc.; Phoenix (AZ); Hybrid; USD 90,000 - 120,000; Full time

Job summary

W. L. Gore & Associates, Inc. is seeking a Quality Assurance Professional to join Gore Medical Quality Assurance in Phoenix.

You'll work with cross-functional teams to support day-to-day manufacturing, execute NCR, CAPA, Change Management, and other quality system processes, and implement corrective actions. The role is located at our Phoenix facility with a hybrid work arrangement. You will monitor post-implementation effectiveness and ensure audit readiness, collaborating across product lines

Qualifications

• 4+ years of QA experience in a regulated medical device or biotech industry.
• Working knowledge of FDA medical device quality system regulations and ISO standards.
• Excellent written and oral communication skills and collaboration.
• Ability to travel up to 5%

Responsibilities

• Support day-to-day manufacturing with CAPA and nonconformance investigations across cross-functional teams.
• Coordinate NCR and CAPA processes and track corrective actions.
• Maintain audit readiness and assist in audit preparation and coordination.
• Collaborate with QA and cross-functional teams to enable timely quality decisions.
• Support NCR, CAPA, Change Management, FIR and operational improvements.
• Guide manufacturing through daily quality system issue resolution and documentation.
• Train others on quality system requirements and good documentation practices.
• Participate in and perform quality system compliance audits.
• If needed, coordinate FIR from initiation to completion with proper approvals.
• Enhance quality systems, including software implementation and validation.

Skills

Quality Assurance

FDA QSR knowledge

ISO 13485

Communication skills

Interpersonal skills

Conflict resolution

Independent work

Time management

Cross-functional collaboration

Education

Bachelor's in science or engineering

2-year degree + 2+ years medical device experience

Tools

ERP systems

PLM systems

Job description

About the Role

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
• Conflict resolution 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
• ISO 13485 Lead Auditor Certification
• 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.