Full-Time at W.L. Gore & Associates Inc, Flagstaff, AZ
posted on September 29, 2012
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.
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 Maintenance/Calibration (M&C) Specialist to join our 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 2002.
If you are searching for a company where you can make a difference, we're looking for you. In this role, you will maintain the M&C and document control systems in compliance with applicable regulations (21 CFR 58, 21 CFR 820, ISO 13485).
The ideal candidate will:
- Be passionate about coordinating and maintaining M&C-related systems and documentation 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
- The paper-based file for equipment (e.g., calibration records, purchase orders, service agreement)
- The calibration database (Blue Mountain)
- Controlled copies of released and obsolete documents
- Generating work orders
- Assigning equipment numbers
- Assisting associates in:
- Preparing the documentation for new and/or removed equipment
- Revising documents and the change-control process
- Searching and creating documents in the document database system (Agile PLM system) and internal system.
- Managing the change-control process for documents in paper and database (e.g., released and obsolete documents)
- Developing solutions when unique situations arise concerning system usage
- Assisting during internal and external audits
- Supporting training sessions related to M&C and document control
- Interacting with multiple teams regarding issues with M&C and document-control systems
- Participating as a member of the Quality Assurance team, supporting the team in achieving functional goals and team projects
Required Job Qualifications
- High school diploma or GED
- Problem-solving knowledge
- Excellent computer skills
- Excellent written and oral communication skills
- Excellent customer-service skills
- Strong interpersonal skills
- Positive attitude
- Familiarity with or ability to learn GLP/QSR/ISO/EN standards as they relate to calibration and document control
- Demonstrated ability to work independently, as well as part of a diverse team
- Ability to:
- Set and meet aggressive timelines
- Understand, interpret, and enforce the Medical Products Division Quality System and clearly communicate its requirements to other associates
- Coordinate activities with cross-functional associates
Desirable Job Qualifications
- Knowledge of computer applications such as Agile/PLM, Microsoft Access and Visio, Adobe Acrobat, Blue Mountain, etc.
- Knowledge of GLP and quality-system requirements
Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening.
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Job Number: 123209
Job Type: Experienced Professional
Job Function: Manufacturing/Operations
Primary Location: North America -United States -Arizona -Flagstaff
Travel: Yes, 5 % of the Time
Shift: Day (1st shift)