Software Quality Assurance Computer Systems Validation Specialist - Remote

Required Qualifications:

• Minimum 5 years of experience in a computer system validation role in the medical device, pharmaceutical, biotech, or other regulated industry
• Demonstrated experience in software quality assurance processes, SDLC methodology (Waterfall and Agile approaches), supplier quality management, change management, defect/incident/issue/problem investigation, root cause determination, corrective & preventive action execution, documentation, verification, periodic review, and validation techniques
• Demonstrated experience in software validation documentation and validation principles, including IQ, OQ, and PQ, for both custom and off-the-shelf software/firmware systems
• Proven experience developing full validation documentation and testing protocols within the various SDLC phases that is scalable and maintainable to demonstrate continuous compliance
• Understanding of current software quality-assurance techniques and software industry standards and their impact on internal procedures, and software quality
• Proficiency in interacting with internal and external individuals and teams (e.g. project teams, vendors, and regulatory authorities)
• Excellent written and oral communication skills
• Demonstrated ability to handle multiple projects and priorities with competing resources
• Ability to communicate clear direction, commitments, and alignment
• Ability to travel up to 10%

Desired Qualifications:

• Experience with ERP, Product Lifecycle Management Systems, and/or Manufacturing Execution Systems, for example: SAP S/4 HANA ERP; HP Application Lifecycle Management (ALM); SAP Solution Manager; SAP MES (ME/MII); Siemens Opcenter Camstar MES
• Experience with Digital Transformation projects
• Experience with ALM software, IT Service Management (ITSM) e.g. ServiceNow, and Agile Project Management tools e.g. Atlassian Jira

Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore’s remote working policies, from the country in which they are employed. ​For fully remote roles, the following locations are not eligible for new fully remote work arrangements: Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only). 

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

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 an equal opportunity employer. We welcome all applications irrespective of 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 covered 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 U.S. Gore generally will not sponsor visas unless otherwise noted on the position description. 

Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact