What are the responsibilities and job description for the Engineer I Quality Systems and Regulatory Compliance position at Arthrex?
Requisition ID: 60523
Title: Engineer I Quality Systems and Regulatory Compliance (AMIE)
Division: Arthrex Manufacturing Inc (US02)
Location: Ave Maria, 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 I Quality Systems and Regulatory Compliance for our Ave Maria, FL Manufacturing Site. The Engineer I 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:
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 Benefits
Title: Engineer I Quality Systems and Regulatory Compliance (AMIE)
Division: Arthrex Manufacturing Inc (US02)
Location: Ave Maria, 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 I Quality Systems and Regulatory Compliance for our Ave Maria, FL Manufacturing Site. The Engineer I 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:
- Responsible for participating in QSRC projects and assisting in assuring the Arthrex QMS meets all requirements.
- Responsible for 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.
- Assist QSRC Supervisor 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 QSRC Manager.
- Assist in maintaining External Audit files in accordance with established procedures and SOPs.
- Assisting in the writing of Arthrex QMS SOPs.
- Responsible for assisting/leading NCR or CAPA investigations.
- Responsible for assisting in compiling and reporting on Arthrex QMS / Compliance metrics.
- Assist in the preparation of audit responses, both Internal and External.
- Bachelor’s degree in Engineering or Engineering Technology required.
- Experience in a Quality Control or Quality Assurance position in a Medical Device Company preferred.
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 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)