A global medical device company and a leader in new product development and medical education in orthopedics is actively seeking a Quality Systems and Regulatory Compliance Engineer II who will work directly with the Global CAPA teams. This will be responsible for supporting the Manager – Global CAPA with all quality related support for improving and maintaining the global Quality Management System (QMS) to ensure compliance to FDA QSR, ISO 13485, and all other applicable regulatory requirements. Excellent communications and analytical skills, strong project management skills and a Bachelors’ degree in an Engineering discipline will be essential for this position.
Essential Duties and Responsibilities:
- Responsible for participating in QSRC projects and assuring the QMS meets all requirements.
- Responsible for reviewing root cause analyses, effectiveness review plans and NC/CAPA documentation for QMS compliance.
- Work with 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.
- Responsible for writing and/or assisting in the writing of QMS SOPs.
- Responsible for assisting/leading NCR or CAPA investigations.
- Responsible for assisting in compiling and reporting on QMS / Compliance metrics.
- Responsible for writing and/or assisting in the writing of audit responses, both Internal and External.
- Other duties as assigned
This is an in-office position located in Naples, Florida; it is not a remote position.
Education and Experience:
- Bachelor’s degree in an Engineering discipline 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.