Quality Assurance Professional

Company: W.L. Gore & Associates
Location: Phoenix
Posted on: November 19, 2023

Job Description:

About Us: Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our Associates.

About the Industry: Saving lives and improving the quality of life for patients is at the core of everything we do. This meaningful work gives purpose to our lives and inspires us to create solutions that make a difference in the lives of others. Learn more at gore.com/products/industries

About the Role: We are looking for a Quality Assurance Professional to join our Commercial Manufacturing Support QA and Labeling QA teams. This person will work on a cross-functional team to support day-to-day manufacturing, plant, and labeling process operations, including NCR, CAPA and other quality systems, addressing product issues, defining, and implementing effective corrective actions, and monitoring post-implementation effectiveness. It is expected that this will be a 50% Labeling QA and 50% Manufacturing Support QA commitment.

This position will be located at our facility in Phoenix, Arizona, with the possibility of a hybrid remote work arrangement, depending upon the responsibilities of the role and business needs.

Responsibilities:

• Partner with labeling team on development and review of artwork and bitmap files
• Ensure product labels meet procedural requirements for defined regions
• Support the day-to-day manufacturing process and provide hands-on coordination and support for nonconforming product (NCR) investigations, failure investigations (FIR), and corrective and preventive actions (CAPAs) from initiation to completion to ensure systematic issues are addressed in a timely manner
• Help manufacturing, packaging, boxing, sterilization, and labeling with daily issues related to quality-system requirements
• Lead audit readiness for labeling and final product processing areas
• Train and educate others on quality-system requirements and good documentation practices to help ensure compliance
• Advise various teams (e.g., labeling, sterilization, packaging, manufacturing, document control, maintenance and calibration, environmental monitoring and control, etc.)
• Develop procedures and initiate change documentation in support of new and existing products
• Develop quality reports to support assessments of quality-system effectiveness
• Partner with other associates and facilities on projects to improve procedures, processes, and the quality system
  
  Required Qualifications:
  
  • Minimum 4 years of Quality Assurance 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
  • Strong knowledge of medical device OR pharmaceutical labeling requirements/standards
  • Excellent written and oral communication skills
  • Strong Interpersonal and influence skills
  • Conflict resolution skills
  • Ability to work independently, as well as part of a diverse team
  • Ability to set and meet aggressive timelines
    
    Desired Qualifications:
    
    • Bachelor's degree in an applicable science or engineering and / or Lead Auditor Certification
    • Strong knowledge of E1 and PLM Systems
    • Experience supporting labeling
      
      Hybrid Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore's hybrid working policies, from the country in which they are employed.
      
      What We Offer: At Gore, we offer comprehensive, competitive rewards in the form of compensation and benefits. Among these are work-life balance and sports programs, 401(k) Plan with a gift, Associate Stock Ownership Plan, health & well-being program with full health plan, and a flexible working program. Within Gore, you will find a unique culture, diversity, equity, and inclusion initiatives, and opportunities for growth and development. Learn more at gore.com/careers
      
      We believe in the strength of a diverse workforce and inclusive work environment. In support of our values and continued success we are proud of Associates around the world who support an inclusive work environment, strive to reflect the diversity of the communities where we operate, and ensure all Associates and external partners are treated with fairness, dignity and respect.
      
      Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening.
      
      Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.
      
      Gore is a M/F, Disabled and Vet EEO/AA employer. (Applies to all positions in the U.S.)
      
      Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact

Keywords: W.L. Gore & Associates, Phoenix , Quality Assurance Professional, Accounting, Auditing , Phoenix, Arizona