Arthrex, Inc. is looking to evaluate medical device products to determine if investigations are required, following all applicable FDA 21 CFR 820 regulations and ISO 13485:2016 standards.
Requirements
- Proficiency in the use of PC and MS Office programs, particularly MS Excel and MS Word preferred
- Familiarity with electrical and mechanical testing tools and methods preferred
- Experience collecting and documenting data
- Ability to work independently or on a team to assure functional commitments are met
- Strong analytical skills, and ability to process data and draw appropriate conclusions
- Experienced in trending data
- Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements
Responsibilities
- Conducts complaint evaluations and investigations and ensures all findings are properly documented
- Evaluate and test returned product according to established specifications, drawings, and procedures
- Collect and record data in appropriate formats as part of continuous improvement
- Perform functional testing according to measurement and analysis procedures and or pass/fail criteria
- Confirm by objective evidence any non-conformances reported or observed with the product
- Works with various Engineering teams to facilitate complaint investigations based on technical complexity and determine non-conformance root cause(s)
- Analyze historical complaints and investigations for trending analysis
Other
- High School or equivalent required
- Experience in a regulated environment preferred
- Ability to define problems, collect data, establish facts, and draw valid conclusions
- Ability to verbally communicate ideas and issues effectively to other team members and management
- Ability to write and record data and information as required by procedures
- Must be able to lift and/or move up to 10 pounds and occasionally bend and lift/move up to 50 pounds
