Quality Control Testing

W. L. Gore & Associates, Inc.; Flagstaff (AZ); On-site; USD 36,000 - 41,000; Full time

Benefits offered by this job

Day-1 benefits inclusion

Job summary

Gore is seeking an associate to provide Raw Material quality inspection on the 1st shift at Woody Mountain in Flagstaff, Arizona. The role involves receiving, quality acceptance, inventory management, and testing using hand and automated instruments in a warehouse/cleanroom setting.

The position requires rigorous adherence to SOPs and QSRs, with duties spanning data entry, testing, and collaboration with teams. Candidates must meet visual acuity tests and demonstrate strong attention to detail.

Qualifications

• Minimum 4 years in manufacturing within a regulated medical device environment or 2+ years in a quality control function in such a setting.
• Must pass visual acuity test.
• Knowledge of Quality System Regulations (QSR) and GMP concepts.
• Basic math/analytical skills; ability to learn statistical concepts for manufacturing quality.
• Demonstrated attention to detail and ability to follow SOPs precisely.
• Effective written and verbal communication; able to work independently and in teams.
• Experience using manual/automated measurement equipment (calipers, rulers, instruments).

Responsibilities

• Perform RM quality acceptance activities per SOPs.
• Set up equipment and operations for testing.
• Conduct tests using predetermined methods and specifications.
• Interpret blueprints, diagrams, customer specs and checklists.
• Enter data and use PLM/AGILE, Docusphere, and ERP systems.
• Perform hand assembly and visual inspection.
• Develop strong interpersonal relationships.
• Ability to sit/stand/walk; lift 10–50 lbs as required.
• Work at heights greater than 10 feet.

Skills

Attention to detail

Strong math/analytical skills

Effective communication

Independent work

Teamwork

Quality decision making

Verbal/written instructions

Tools

Calipers

Ruler

Instron tensile tester

Pipette

SAP navigation

AGILE PLM

Docusphere

Job description

About the Role

The Raw Materials Team is seeking an associate to provide Raw Material (RM) Quality Inspection on 1st shift at Woody Mountain in Flagstaff, Arizona.This is a commitment that will provide support tothe division in a warehouse, cleanroomand testing environment. This associate will beresponsible forreceiving, performing quality acceptance activities,warehouse receipt,and usinghand measurement/automated testing instruments torelease RM and components into inventory locations as well asreceiving and completinginventory management activities. In addition, the selected associate will be expected to participate in, or champion coordinated process/systems improvements.

This role will be located at our facility in Flagstaff, Arizona.

Pay and Benefits:

• $26.50 - $30.50 per hour
• This role is eligible for an additional $2/hour shift differential pay for evening, night, and weekend shifts (in California, the shift differential pay is $2.40/hour).
• 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 atwww.gore.com/careers/benefits

Responsibilities

• Performing Raw Materials acceptance activities per standard operating procedures (SOP's)
• Setting up equipment and operation
• Using predetermined methods, operations, setups, and prescribed specifications to perform tests
• Using blueprints, diagrams, customer specification, drawings or quality testing instructions and checklists
• Performing data collection/computer entry, daily interaction with PLM (AGILE), Docusphere, and E1/ERP
• Performing hand assembly and visual inspection
• Developing and maintaining strong interpersonal relationships
• Being able to sit, stand, walk regularly
• Demonstrating the ability to occasionally lift 10-20 lbs. repeatedly; frequently lifting 30-50 lbs. as required
• Being able to work at heights greater than 10 feet

Required Qualifications

• Minimum 4 years' experience working in manufacturing within a regulated medical device manufacturing company and or a minimum of 2 years' experience in a quality control unit/ function in a regulated medical device manufacturing company or equivalent test lab experience
• Successfully pass visual acuity test
• Knowledge and application of Quality System Regulations
• Basic math/analytical skills and ability to learn basic statistical concepts and tools as they apply to manufacturing quality
• Demonstrated attention to detail
• Understands and follows verbal and written instructions and standard operating procedures
• Effective communication skills, both written and verbal
• Demonstrated effectiveness working independently and in a team environment
• Ability to use manual/automated measurement equipment ( e.g. calipers, ruler, Instron tensile tester, pipette, etc.)
• Ability to interpret requirements, make quality decisions, and elevate issues as necessary

This role requires pre-hire medical clearance by Gore which may include testing to assess visual acuity and/or the ability to wear specific safety equipment as required during the performance of the role.

Desired Qualifications

• Ability to read and understand blueprints, detailed specification drawings and execution of Raw material incoming Inspection procedures.
• Experience with SAP navigation and completion of raw material inspections.

What We Offer

Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.

We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for "profit-sharing". Learn more at gore.com/careers/benefits

Gore is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a protected veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.

Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.

Gore requires all applicants to be eligible to work within the United States. Gore generally will not sponsor visas unless otherwise noted on the position description.