Engineer I QA - Manufacturing

Arthrex Manufacturing - Corkscrew, FL

Full-time - Entry Level

Corkscrew, FL

Miscellaneous 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 an Engineer I QA for our Ave Maria, FL Manufacturing Site. The ideal candidate will have a Bachelor's degree in Engineering and a passion for providing superior quality products and services to those we serve. This position is integral to our commitment to quality and excellence in the medical device industry, focusing on helping surgeons treat their patients better. As an Engineer I QA, you will be responsible for collaborating with Design and Manufacturing Engineering teams to prevent quality discrepancies. You will help determine the root cause of issues and drive corrective actions with the guidance of Quality Engineers. Your role will include reviewing Device History Records (DHR), conducting inspections, performing functional testing, and writing evaluation reports. You will execute activities related to the development, application, and maintenance of quality standards for industrial processes, materials, and products. In this position, you will initiate standards and methods for inspection, testing, and evaluation, utilizing your knowledge in engineering fields such as chemical, electrical, or mechanical. You will devise sampling procedures and design forms and instructions for recording, evaluating, and reporting quality and reliability data. Additionally, you will execute established programs to evaluate the precision and accuracy of production equipment and testing, measurement, and analytical equipment and facilities. You will also be responsible for developing methods and procedures for the disposition of discrepant material and assessing cost and responsibility. Compiling and writing training material and conducting training sessions on quality control activities will also be part of your responsibilities. You may assist in areas of Quality Control, Manufacturing Engineering, Metrology Process Control, Product evaluation, customer complaints, Research and Development, and Receiving Inspection.

Responsibilities

• Collaborate with Design and Manufacturing Engineering to prevent quality discrepancies.
• Determine root causes of quality issues and drive corrective actions with Quality Engineers.
• Review Device History Records (DHR), conduct inspections, and perform functional testing.
• Write evaluation reports based on inspections and testing results.
• Develop and maintain quality standards for industrial processes, materials, and products.
• Initiate standards and methods for inspection, testing, and evaluation.
• Devise sampling procedures and design forms for quality data recording and reporting.
• Evaluate precision and accuracy of production and testing equipment.
• Develop methods for the disposition of discrepant materials and assess cost and responsibility.
• Compile and write training materials and conduct training sessions on quality control activities.

Requirements

• Bachelor's degree in Engineering required.
• Experience in a Quality Control or Quality Assurance position in a Medical Device Company preferred.
• Knowledge of testing equipment, statistical methods, and control plans.
• Proficiency in PC programs, particularly Excel and Word, and inventory software like QAD.

Nice-to-haves

• Experience with quality assurance methodologies in a medical device context.
• Familiarity with regulatory requirements in the medical device industry.

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)