Remote Quality Engineer Medical Device Jobs in Oregon

Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. We are actively seeking a Software QA Engineering Manager with strong critical thinking skills and a passion for learning new technologies to support our Engineering teams. In this role, the Software QA Engineering Manager will lead and support a team of software quality engineers responsible for testing and performing quality analysis of application functionality. This work ensures that Arthrex business systems meet defined user requirements, function as intended, and comply with established quality management standards and regulatory expectations. The ideal candidate will collaborate closely with cross-functional engineering teams to promote software quality throughout the development lifecycle while helping drive continuous improvement in testing practices, tools, and processes. Strong communication skills, analytical thinking, and technical project management experience are essential for success in this role. Join our talented team at Arthrex, a global medical device company dedicated to Helping Surgeons Treat Their Patients Better.

Main Objective: 

Leadership and management of overall Software Quality Assurance activities and processes for the Arthrex ADI Team.

Essential Duties and Responsibilities:

• Lead, develop and manage overall Software QA activities and SDLC workflow for medical device software applications
• Promote industry SDLC best practices
• Develop, maintain and approve QA processes to ensure the highest quality for product delivery
• Plan QA projects, balance QA resources, and maintain product quality metrics
• Understand product requirements and review test plans, scripts, and test cases written by the team members
• Participate in test script execution whenever necessary
• Review test results and release documentation
• Work closely with various application and software development teams to coordinate development and testing activities
• Work closely with software validation team to ensure processes are followed for all validated systems
• Participate as a key member of SDLC management and Arthrex leadership teams
• Ensure compliance within functional area and support the compliance objectives of the organization as a whole

Incidental Duties:

The above statements describe the general nature and level of work being performed in this job.  They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Education and Experience:

• Bachelor's degree required: degree in Computer Science, Engineering or related field preferred
• Master's degree in Computer Science or MBA a plus
• At least ten years of experience in Software Quality Assurance, client server and web applications required
• Experience managing geographically distributed teams working on multiple concurrent development projects required
• Experience balancing QA resources between software development projects to meet strategic objectives and product management prioritization required
• Experience with testing custom cloud hosted, embedded, and SaMD applications preferred
• Working Knowledge of Atlassian, Xray Test Management, or equivalent Test Management tools preferred
• Strong Project Management Experience required
• Experience in an FDA regulated environment preferred
• 5 years management or direct supervision experience required
• PMP certification preferred
• Hands on experience in thorough testing of application changes and implementations
• Experience analyzing Requirements, risk analysis and test development
• Experience in setting up QA Key Performance Indexes (KPI)

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Knowledge of Testing Center of Excellence (TCOE)
• Strong knowledge of the Software Development Life cycle and QA's role in it
• Solid understanding of several technologies including relational databases and SQL
• Demonstrated ability to document test plans, test cases, test results
• Documentation of test plan and test summary report
• Excellent communication skills and customer service orientation
• Experience using Product Lifecycle Management (PLM) software for medical device development

Machine, Tools, and/or Equipment Skills:

Work with standard current computer applications, word processing, spreadsheets, Microsoft .Net/C#, Windchill PLM, Atlassian, Xray Test Management.

Arthrex Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Gym Reimbursement Program
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)
• Eligible for discretionary Long Term Incentive program

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.