Senior QA Manufacturing Engineer – Medical Devices

NCSL International; Ave Maria (FL); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

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)

Job summary

Arthrex, Inc. in Ave Maria, FL, is seeking a Senior Quality Assurance Engineer to support the life cycle development of Class I-III medical devices with a focus on manufacturing quality and process validation.

You will partner with the Quality Manager to drive design controls, risk assessments, and cross-functional quality improvements, ensuring compliance and robust product quality across the organization.

Qualifications

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

Responsibilities

• Review design drawings for tolerance, inspect-ability and quality of design issues.
• Work with suppliers to improve quality and assist in supplier validations.
• Assist in training QC Inspectors on inspection techniques and new equipment.
• Participate in internal and external quality audits.
• Lead or participate in PFMEAs and Risk Assessments.
• Support Engineering Change Management processes.
• Lead or support First Article Inspection and reports.
• Lead or support IQ/OQ/PQ validations.
• Lead metrology with inspection methods and Gage R&R studies.
• Create or review inspection plans for receiving and in-process inspection.
• Investigate complaints with the QA/Reliability team.
• Lead NCRs, CAPA actions, and trend analysis.
• Support Continuous Improvement projects and Environmental Monitoring.
• Perform DOE studies as needed.
• Other duties as assigned.

Skills

Design Controls

GD&T

DOE

Process Verification

Validation

SPC

Lean

DMAIC

Kepner-Tregoe

5 Whys

Risk Assessment

PFMEA

Control Plans

Quality Plans

Communication

Project Management

Education

Bachelor's degree in Engineering

Tools

Excel

Word

Minitab

SAP

Pilgrim

QMS software

Agile

Job description

Arthrex, Inc. in Ave Maria, FL, is seeking a Senior Quality Assurance Engineer to support the life cycle development of Class I-III medical devices with a focus on manufacturing quality and process validation.

You will partner with the Quality Manager to drive design controls, risk assessments, and cross-functional quality improvements, ensuring compliance and robust product quality across the organization.