About the Role

We are looking for a Quality Assurance Professional to join the Gore Medical – Surgical Solutions 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 Nonconformance, 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 Elkton, Maryland, with the possibility of a hybrid work arrangement.

Pay and Benefits:

• $96,000 - $132,000 per year
• Factors considered in extending an offer within this pay range include (but not limited to) education, experience, knowledge, skills, and abilities.
• Medical, Dental and Vision benefits effective on Day 1 of employment! We offer a comprehensive total rewards package, including competitive benefits.  More details are available at www.gore.com/careers/benefits

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 nonconformance (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 nonconformance (NCR), CAPA, change management, failure Investigation (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 completed
• Enhance quality systems (including software implementation and validation)

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 influencing skills (ability to teach and gain alignment cross functionally)
• 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 10% of time

Desired Qualifications

• Bachelor’s degree in an applicable science or engineering, OR a 2-year degree plus 2-5 years of medical device experience in a manufacturing or operations role 
• Experience supporting various manufacturing processes
• Experience with 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.