Quality Assurance Professional

Description

Gore is a technology-driven global company built on entrepreneurial innovation, integrity, and teamwork. Through our product leadership, we've been changing lives and changing industries, including medical devices, fabrics, electronics, and manufacturing, for more than 50 years. What can you change by joining Gore? Visit gore.com/change-life to find out.

 

Job Description

Gore Medical Products has provided creative therapeutic solutions to complex medical problems for 35 years, saving and improving the quality of lives worldwide. As a leading manufacturer of vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, and sutures, we are looking for a Quality Assurance Associate to join our Cardiovascular Products Quality Assurance team in Flagstaff, AZ.

 

Just 150 miles north of Phoenix and 80 miles south of the Grand Canyon, Flagstaff is an ideal place to join Gore and change. Surrounded by pine forests and mountains, Flagstaff offers natural beauty, small-town charm, a vibrant educational community, and a diverse culture. Outdoor enthusiasts enjoy all four seasons here, with 300 days of sunshine and a variety of recreational activities. A major employer in Arizona's growing bioscience sector, Gore has led Flagstaff's growth in medical-device jobs since 1975.

 

If you are searching for a company where you can make a difference, we're looking for you. In this role, you will work on cross-functional teams to address product issues, define and implement effective corrective actions, and monitor post-implementation effectiveness.

 

The ideal candidate will:

• Be passionate about quality system processes and their continuous improvement in support of state-of-the-art implantable medical devices
• Be energized by working for a world-class manufacturer and collaborating on cross-functional teams
• Recognize the importance of building and maintaining strong interpersonal relationships

Responsibilities include:

• Making operational improvements
• Performing product development and design control activities
• Enhancing quality systems (including software implementation and validation)
• Performing compliance audits
• Qualifying and approving suppliers
• Training, teaching, coaching, and mentoring associates

Other responsibilities may include:

• Advising various teams (e.g., raw materials inspection, document control, maintenance and calibration, environmental monitoring and control, etc.)
• Developing procedures and initiating change documentation in support of new and existing products
• Developing quality reports to support assessments of quality-system effectiveness
• Reviewing complaints

Qualifications

Required Job Qualifications

• A minimum of 3 years' experience in a Quality Assurance role in a medical-device, pharmaceutical, biotech, or other regulated industry 
• Strong knowledge of/experience with quality system implementation and maintenance
• Excellent written and oral communication skills
• Strong interpersonal skills
• Conflict resolution skills
• Ability to:
  • Work independently, as well as part of a diverse team
  • Set and meet aggressive timelines

Desired Job Qualifications

• Bachelor's degree in an applicable science or engineering
• Sound knowledge of FDA medical-device quality system regulations and ISO medical-device standards
• Experience working with endovascular and catheter-based technologies

Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening.

 

EEO/AA Employer

 

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Job Number: 140032
Job Type: Experienced Professional
Job Function: Quality
Primary Location: North America, United States, Arizona, Flagstaff


Travel: Yes, 5 % of the Time
Shift: Day (1st shift)

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