| Job ID: # 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. 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 · 5+ years experience in a Quality Assurance role in medical device, pharmaceutical, or biotech industry · bachelor's degree in an applicable science or engineering OR a two-year degree plus significant medical device, pharma or biotech experience in a Quality Assurance role preferred · Ability to demonstrate sound knowledge of quality system regulations (FDA regulations/applications, ISO standards) · Strong knowledge/ experience with quality systems implementation and maintenance · Demonstrated excellent written and oral communication skills · Strong interpersonal skills · Conflict resolution skills · ability to work independently, as well as part of a diverse team · ability to set and meet aggressive timelines · Experience working with Endovascular and catheter-based technologies is desirable EEO/AA Employer Job
: Quality Primary Location
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