Engineer I QA Validation

Arthrex, 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 I QA Validation who is 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.

Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

• Responsible for writing of protocols and conducting validations of special processes, including laser marking, passivation, laser welding, molding, etc.
• Responsible for reviewing and approving validations of special processes performed at all Arthrex facilities
• Facilitate the execution of protocols by working closely with Engineering, Operations, Quality Control, and other manufacturing functions.
• Responsible for measuring validation parts and perform analysis of data generated from validations to evaluate process capability.

Education and Experience:

• 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 and Skill Requirements/Specialized Courses and/or Training:

Knowledge of testing equipment, statistical methods, control plans.

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), QAD or similar inventory software.

Reasoning Ability:

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardizations exist. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Mathematical Skills

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements. 

Language Skills:

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.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to talk or hear.  The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. 

Vision Requirements:

Visual acuity necessary to do the job safely and effectively. 

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The area that this job is performed in is a general office or open cubicle/workstation environment.  The noise level in the work environment is usually moderate.

Arthrex 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)

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.