Quality Assurance Professional
3 weeks ago
**About the Role**: We are looking for a Quality Assurance Professional to join our team. In this role, you will work on a cross-functional team to support day-to-day manufacturing and plant operations, including executing the NCR, CAPA and other quality systems, addressing product issues, defining and implementing effective corrective actions, and monitoring post-implementation effectiveness.
This position will be located at one of our facilities in Flagstaff, Arizona, with the possibility of a hybrid remote work arrangement, depending upon the responsibilities of the role and business needs.
**Responsibilities**:
- Support the day to day manufacturing process including problem solving, CAPA and nonconformance investigations and respond with appropriate risk based decision making
- Provide hands-on coordination and support for execution of the nonconforming product (NCR) and corrective and preventive actions (CAPA) processes
- Provide hands-on coordination and investigation of failure investigations (FIR) from initiation to completion to ensure time-sensitive activities, documentation and approvals are completed
- Work and communicate with the QA and cross functional teams as well as non-QA organizations across the product line and MPD to support a quick and robust decision-making process in support of quality system requirements
- Support prioritized activities, including NCR, CAPA, FIR and operational improvements
- Help manufacturing with daily issues related to quality system requirements
- Train and educate others on quality-system requirements and good documentation practices to help ensure compliance
- Participate in and perform quality system compliance audits
- Provide hands-on mentoring and guidance for situational compliance issues
- Develop quality reports and metrics to support assessments of quality system effectiveness and product line goals and objectives
**Required Qualifications**:
- Minimum 4 years of Quality Assurance related experience in a medical-device, pharmaceutical, biotech or other regulated industry
- Demonstrated working knowledge of FDA medical device quality system regulations and ISO medical device industry standards
- Excellent written and oral communication skills
- Strong interpersonal and influence skills
- Conflict resolution skills
- Ability to work independently, as well as part of a diverse team
- Ability to set and meet aggressive timelines
**Desired Qualifications**:
- Bachelor’s degree in an applicable science or engineering, OR a 2-year degree plus 2-5 years medical device experience in a manufacturing or operations role
- ISO 13485 Lead Auditor Certification
- Experience working with cardiac, vascular or catheter-based technologies
Hybrid Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore’s hybrid working policies, from the country in which they are employed.
**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 believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.
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 U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.
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