Requisition ID: 55389 Title: QA Engineer - Software and Equipment Validation Division: Arthrex Manufacturing Inc (US02) Location: Ave Maria, FL

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a QA Engineer - Software and Equipment Validation for our Ave Maria, FL Manufacturing Site who will support the AMI Validation Manager with all process validation related support for the life cycle development and manufacturing of Class I, II, and III medical devices. The successful candidate will have a Bachelors' degree in Engineering, knowledge of continuous improvement methodologies, and manufacturing. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

• Ensure appropriate regulations, such as 21 CFR Part 11, 820 and cGMP regulations, are addressed in validation.


• Coordinate, assist and document validation activities; preparation/approval of protocols and reports.


• Draft, review and approve local validation and compliance documents supporting GxP computerized systems, and relevant infrastructure, including those related to system procurement, audit, performance, compliance evaluation, and validation. Examples include SOPs, qualification protocols, gap assessments, risk assessment, Impact Assessment, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change controls.


• Perform revalidation and change control validation related activities.


• Assist validation activities of cross functional teams that include technical functions such as Information Systems, Manufacturing and QA Engineering, business owners.

Education and Experience:

• Bachelor's degree in computer science, technology or related field required


• Experience in the validation of computer systems, manufacturing, packaging, equipment and process, as well as utilities, and facilities qualification preferred.


• Experience in thorough testing of applications, computerized systems, changes and implementations preferred.

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

• Thorough understanding of FDA regulations and computer validation guidance documents


• Familiarity with GAMP and other approaches to System Development Life Cycles (SDLC), CAPA.


• Computer knowledge of 21 CFR Part 11, CFR 820

• Excellent communication skills and customer service orientation

Machine, Tools, and/or Equipment Skills:

PC servers, workstations and laptops. Microsoft environment. Work with standard current computer applications, such as word processing, spreadsheets and data bases.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.

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