Engineer II - Quality Systems & Regulatory Compliance

Requisition ID: 59140  Title: Engineer II - Quality Systems & Regulatory Compliance  Division: Arthrex, Inc. (US01)  Location: Naples, FL 

 

 

 

 

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 II Quality Systems and Regulatory Compliance who is responsible for supporting the Quality Systems and Regulatory Compliance (QSRC) Manager with all quality related support for improving and maintaining the Arthrex global Quality Management System (QMS) to ensure compliance to FDA QSR, ISO 13485, and all other applicable regulatory requirements. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

 

Essential Duties and Responsibilities:

• Participating in QSRC projects and assuring the Arthrex QMS meets all requirements.
• Reviewing root cause analyses, effectiveness review plans and NC/CAPA documentation for Arthrex QMS compliance.
• Work with Arthrex QE’s to improve quality and assist, where necessary, in CAPA investigations.
• Train and/or assist Manager – Global CAPA in the training of QE’s and Subject Matter Experts (SME’s) on Arthrex QMS procedures, root cause analysis, effectiveness review planning and QMS software / programs.
• Participate in Internal and External quality audits as directed by the Manager – Global CAPA.
• Writing and/or assisting in the writing of Arthrex QMS SOPs.
• Assisting/leading NCR or CAPA investigations.
• Assisting in compiling and reporting on Arthrex QMS / Compliance metrics.
• Writing and/or assisting in the writing of audit responses, both Internal and External.

 

Education and Experience:

• Bachelor’s degree in Engineering or Engineering Technology required.
• 2+ years experience in a Quality Control or Quality Assurance position required; preferably in a Medical Device company.

 

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

Knowledge of testing equipment, statistical methods, control plans.

Experience in leading CAPA activities, specifically root cause analysis and effectiveness review planning.

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), Agile, SAP or similar inventory software as well as CAPA, NCR, Audit or Complaint Management software.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions.  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills

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

Language and Communication 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.

 

Arthrex 2023 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 or protected veteran status.