Regulated QA

About the Role

We are looking for a Quality Assurance Professional to join our Quality Manufacturing Commercial Support team who will work on a cross-functional team to support day-to-day manufacturing and plant operations, including NCR, CAPA and other quality systems, 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 respond with appropriate risk based decision making
• Provide hands-on coordination and investigation of failure investigations (FIR) from initiation to completion to ensure time-sensitive activities, documentation and approvals are completed
• Ensure constant audit readiness for product line and assist in audit preparation and coordination to deliver successful audit results
• Work and communicate with cross functional teams to support a quick and robust decision-making process in support of quality system requirements
• Support prioritized activities, including NCR, CAPA, FIR and operational improvements
• Help manufacturing with daily issues related to quality system requirements
• Train and educate others on quality-system requirements and good documentation practices to help ensure compliance
• Participate in and perform quality system compliance audits
• Advise, collaborate with, and influence cross functional teams (e.g. Manufacturing, Engineering, Environmental Monitoring, Maintenance, Regulatory, etc.)
• Perform additional responsibilities as required within the scope of position

Required Qualifications

• Minimum 4 years of Quality Assurance related experience in a medical-device, pharmaceutical, biotech or other regulated industry
• Excellent written and oral communication skills
• Strong interpersonal and influence skills
• Conflict resolution skills
• Ability to understand and apply FDA medical device quality system regulations and ISO medical device industry standards
• 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% of the time

Desired Qualifications

• Bachelor’s degree in an applicable science or engineering, OR a 2-year degree plus 2-5 years medical device experience in a manufacturing or operations role
• Experience working with cardiac, vascular or catheter-based technologies
• Experience supporting various manufacturing processes

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.