Arthrex · 19 hours ago
Engineer II QA - Manufacturing
Immokalee, FL
Full-time
Onsite
Entry, Mid Level
2+ years expArthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for an Engineer II – QA for their manufacturing site in Ave Maria, FL, where the ideal candidate will be responsible for ensuring quality control and assurance processes are followed within the manufacturing environment.
Health CareMedical Device
Responsibilities
Review design drawings for tolerance, inspect-ability and quality of design issues
Work with suppliers to improve quality, and assist, where necessary, in supplier process validations
Assist in the training of QC Inspectors on inspection techniques and the use of new equipment
Participate in Internal and External quality audits as directed by the Quality Assurance Manager
Support Risk Management by leading or participating in cross-functional team pFMEA’s and Risk Assessments
Support the AMI Engineering Change Management process by performing tasks as assigned
Lead or Support the internal manufacturing First Article Inspection process, review First Article Inspection Reports and samples (internal and/or supplier)
Lead or Support equipment or process validation (IQ, OQ, PQ)
Lead or support Metrology with design and development of inspection methods and gages
Create or review inspection method work instructions
Lead or support Metrology with Measurement System Analysis (Gage R&R) studies
Create Inspection Plans Supporting Receiving and In-Process Inspection
Investigate complaints as requested by the Complaints/Reliability team
Lead completion of Nonconformances (NCR’s) as assigned: material disposition plans, evaluations, and action plans
Perform routine Nonconformance and process trending and lead periodic Quality review meetings with the management team
Lead or Support Continuous Improvement projects
Lead or support the Environmental Monitoring program
Complete Root Cause Analysis Investigations and define Corrective/Preventive Action Plans (CAPA’s)
Perform Engineering Studies and Design of Experiments (DOE) as needed
Qualification
Required
Bachelor's degree in Engineering required
Technical knowledge in development methodologies including: Design Controls, GD&T, DOE, Process Verification and Validation
SPC (Statistical Process Control) knowledge
Working knowledge of risk assessments, PFMEAs, control plans, quality plans
Strong communication skills and ability to communicate effectively with technical and non-technical staff
Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), miniTab or similar statistical analysis software, SAP or similar inventory software, Agile or similar design lifecycle software, Pilgrim or similar QMS software
Knowledge of measurement and other inspection equipment
Manufacturing process knowledge
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
Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements
Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above
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
Visual acuity necessary to do the job safely and effectively
Preferred
2 years experience in a Quality Control or Quality Assurance position in a Medical Device Company
Working knowledge of process improvement tools (i.e.: Lean - PDCA, Six Sigma - DMAIC) and problem solving (i.e.: Kepner Tregoe, Lean A3, 5 Whys)
Project management skills
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
Free Onsite Medical Clinics
Free Onsite Lunch
Tuition Reimbursement Program
Trip of a Lifetime
Paid Parental Leave
Paid Time Off
Volunteer PTO
Employee Assistance Provider (EAP)
Company
Arthrex
Arthrex is a global medical device company and leader in new product development and medical education in orthopedics.
10001+ employees
H1B Sponsorship
Arthrex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (30)
2024 (22)
2023 (13)
2022 (13)
2021 (9)
2020 (12)
Funding
Current Stage
Late StageLeadership Team
Eric Butler
Sr. Director - Surgical Imaging & Integration
Kazu Miyahara
Senior Engineering Manager
Recent News
2025-12-24
Company data provided by crunchbase