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Quality Assurance Professional Job
Date: Jul 30, 2010
Location: Flagstaff, AZ, US
Quality Assurance Professional-091177
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.
As a leading company within cardiovascular medical products, we are looking for a Quality Assurance professional to join our rapidly growing Medical Products Division. In an organization dedicated to manufacturing implantable devices that are the highest quality, Quality Assurance at Gore is the place to be!
If you are searching for a company where you can make a difference, we're looking for you. Within this role you will have the opportunity to impact the quality of existing devices during manufacturing as well as next-generation devices during new product design and development.
The ideal candidate will
* Be passionate about solving hands-on product quality issues, implementing effective corrective actions, and monitoring post-implementation effectiveness.
* Be energized by working in a world-class manufacturing facility collaborating on cross-functional teams.
* Recognize the importance of building and maintaining strong interpersonal relationships.
In addition, this associate will focus on:
* Operational improvements
* Product development and design control activities
* Systems enhancement (including software implementation and validation),
* Compliance auditing
* Vendor selection and approval
* Associate training
Further responsibilities may include:
* Initiation of change documentation
* Advisory roles supporting various teams (such as raw materials inspection, document control, maintenance and calibration, environmental monitoring and control, etc.)
* Preparation of quality reports
* Review of complaints
* Development of policies and procedures that affect operational and compliance status
Qualifications
Requirements:
* bachelor's degree in an applicable science or engineering or an equivalent combination of education and applicable quality assurance experience in a medical device or pharmaceutical environment
* 5+ years experience in a quality assurance role in medical device and/or pharmaceutical manufacturing
* knowledgeable with US regulations and International standards pertaining to medical device and/or pharmaceutical manufacturing
* ability and willingness to handle day-to-day quality system issues by taking an active role in defining issues and proposing solutions
* demonstrated excellent written and oral communication skills
* strong interpersonal skills
* able to work independently, as well as part of a diverse team
* able to set and meet aggressive timelines
* logical and analytical problem solver
* ability to troubleshoot issues
* ability to understand technical issues
* ability to demonstrate sound reasoning and judgment
* basic computer literacy
Preferred Experience:
* working with endovascular and catheter-based technologies
* quality systems implementation and maintenance
* supplier and process auditing
* product/process validation
* design control and new product development
* risk management
EEO/AA Employer (applies to positions posted in the U.S. only)
Job
: Quality
Primary Location
: North America-United States-Arizona-Flagstaff
Travel
: Yes, 5% of the time
Shift
: Day (1st shift)
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.
As a leading company within cardiovascular medical products, we are looking for a Quality Assurance professional to join our rapidly growing Medical Products Division. In an organization dedicated to manufacturing implantable devices that are the highest quality, Quality Assurance at Gore is the place to be!
If you are searching for a company where you can make a difference, we're looking for you. Within this role you will have the opportunity to impact the quality of existing devices during manufacturing as well as next-generation devices during new product design and development.
The ideal candidate will
* Be passionate about solving hands-on product quality issues, implementing effective corrective actions, and monitoring post-implementation effectiveness.
* Be energized by working in a world-class manufacturing facility collaborating on cross-functional teams.
* Recognize the importance of building and maintaining strong interpersonal relationships.
In addition, this associate will focus on:
* Operational improvements
* Product development and design control activities
* Systems enhancement (including software implementation and validation),
* Compliance auditing
* Vendor selection and approval
* Associate training
Further responsibilities may include:
* Initiation of change documentation
* Advisory roles supporting various teams (such as raw materials inspection, document control, maintenance and calibration, environmental monitoring and control, etc.)
* Preparation of quality reports
* Review of complaints
* Development of policies and procedures that affect operational and compliance status
Qualifications
Requirements:
* bachelor's degree in an applicable science or engineering or an equivalent combination of education and applicable quality assurance experience in a medical device or pharmaceutical environment
* 5+ years experience in a quality assurance role in medical device and/or pharmaceutical manufacturing
* knowledgeable with US regulations and International standards pertaining to medical device and/or pharmaceutical manufacturing
* ability and willingness to handle day-to-day quality system issues by taking an active role in defining issues and proposing solutions
* demonstrated excellent written and oral communication skills
* strong interpersonal skills
* able to work independently, as well as part of a diverse team
* able to set and meet aggressive timelines
* logical and analytical problem solver
* ability to troubleshoot issues
* ability to understand technical issues
* ability to demonstrate sound reasoning and judgment
* basic computer literacy
Preferred Experience:
* working with endovascular and catheter-based technologies
* quality systems implementation and maintenance
* supplier and process auditing
* product/process validation
* design control and new product development
* risk management
EEO/AA Employer (applies to positions posted in the U.S. only)
Job
: Quality
Primary Location
: North America-United States-Arizona-Flagstaff
Travel
: Yes, 5% of the time
Shift
: Day (1st shift)
Nearest Major Market: Flagstaff
Nearest Secondary Market: Sedona
Job Segments: Administrative, Document Control, Engineer, Engineering, Facilities, Finance, Healthcare, Implementation Manager, Inspector, Maintenance Engineer, Medical Device, Medical Research, Operations, Product Development, QA, Quality, Quality Assurance, Research, Risk Management, Scientific, Technology
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