Senior Engineer - QA Manufacturing

About the Position

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. We are actively searching for a Senior Quality Assurance Engineer for our manufacturing facility in Ave Maria, FL. The Senior Quality Assurance Engineer is responsible for supporting the Quality Manager with all quality-related support for the life cycle development of Class I, II, and III medical devices, including new product development and maintenance of released products. Join our talented team at a growing global medical device company focused on Helping Surgeons Treat Their Patients Better.

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.
• Other duties as assigned.

Requirements

• Education: Bachelor's degree in Engineering required.
• Experience: 5 years quality engineering experience in a highly regulated industry required.

Skills

• Core Skills:
  • Technical knowledge in development methodologies including: Design Controls, GD&T, DOE, Process Verification and Validation.
  • SPC (Statistical Process Control) knowledge.
  • Working knowledge of process improvement tools (i.e.: Lean - PDCA, Six Sigma - DMAIC) and problem solving (i.e.: Kepner Tregoe, Lean A3, 5 Whys).
  • Working knowledge of risk assessments, PFMEAs, control plans, quality plans.
• Secondary Skills:
  • Strong communication skills and ability to communicate effectively with technical and non-technical staff.
  • Project management skills preferred.
  • 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.

We Offer

• 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)

About the Company

Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. We are committed to helping surgeons treat their patients better.

Job Details

• Title: Senior Engineer - QA Manufacturing
• Location: Ave Maria, FL, US, 34142
• Nearest Major Market: Naples
• Requisition ID: 66487
• Date: Oct 27, 2026

Application

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.

Making People Better at Arthrex

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