Engineer I QA Validation

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 Validation who will be responsible for supporting our Ave Maria, FL manufacturing Validation QA team with all process validation related support for the life cycle development and manufacturing of Class I, II, and III medical devices. This role is crucial in ensuring that our products meet the highest standards of quality and compliance, which is essential for our mission of Helping Surgeons Treat Their Patients Better™. The Engineer I QA Validation will be tasked with writing protocols and conducting validations of special processes, including laser marking, passivation, laser welding, molding, and more. This position requires a collaborative approach, as the engineer will facilitate the execution of protocols by working closely with Engineering, Operations, Quality Control, and other manufacturing functions. Additionally, the engineer will be responsible for measuring validation parts and performing analysis of data generated from validations to evaluate process capability. This role is integral to maintaining the quality and reliability of our medical devices throughout their lifecycle. The ideal candidate will possess a strong foundation in engineering principles, particularly as they relate to quality assurance and validation processes. This position offers an exciting opportunity to contribute to the development of innovative medical devices that improve patient outcomes.

Responsibilities

• Write protocols and conduct validations of special processes, including laser marking, passivation, laser welding, and molding.
• Review and approve validations of special processes performed at all Arthrex facilities.
• Facilitate the execution of protocols by collaborating with Engineering, Operations, Quality Control, and other manufacturing functions.
• Measure validation parts and perform analysis of data generated from validations to evaluate process capability.

Requirements

• Bachelor's degree in Engineering or Engineering related technology required.
• Experience in a Quality Control, Quality Assurance or Validation position in a Medical Device Company preferred.
• Knowledge of testing equipment, statistical methods, and control plans.
• Proficiency in the use of PC and programs, particularly Excel, Word, QAD or similar inventory software.
• Ability to solve practical problems and deal with a variety of concrete variables in situations with limited standardizations.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to comprehend and apply mathematical principles as required for the job.
• Ability to communicate ideas and issues effectively to team members and management.

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)