Quality Systems and Regulatory Compliance Specialist, Sr.

4 weeks ago

Naples, United States Arthrex Full time
Essential Duties and Responsibilities:

  • Organizes, documents, and coordinates ongoing projects in Quality Systems to assure the Arthrex QMS meets all applicable requirements.
  • Coordinates and manages quality systems records including any of the following: Corrective and Preventive Actions (CAPA), Nonconformances (NCR), Deviation Records, iPlan inspection plans, and/or Change Management Records with responsible parties to assure adequate compliance to Arthrex QMS requirements.
  • Responsible for the review of Quality Systems Records to assure comliance and completeness to the records.
  • Generates/creates reports against determined measurement criteria for Quality Systems within the QMS.
  • Provide guidance to the users of QMS software and procedures.
  • Assist in writing and/or revision of Arthrex QMS documents.
  • Creates content and supports Quality Systems training activities including cGMP and GDP to new and current employees
  • Assists business/process owners with the development, revision, and review of QMS documents for compliance and completeness.
  • Performs Quality System data trending to assure applicable requirements and management goals are being met.
  • Prepares presentations and related materials for CAPA Review Board and Management Reviews.
  • Supports internal and external audits as Quality Systems SME.

Education and Experience:

  • Bachelor’s Degree required, preferably in Engineering or Science Related study, or related area.
  • Understanding of FDA’s Quality System Regulations (QSR) and ISO 13485 preferred.
  • 7+ years experience with Nonconformances, corrective and preventive actions, ISO 13485

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

  • Working knowledge of ISO 13485 and 21 CFR part 820 – Quality System Regulations preferred. Experience in working with CAPA, Nonconformance Reporting, or Deviation Reporting highly desirable.

Machine, Tools, and/or Equipment Skills:

  • Proficiency in the use of Personal Computers and computer programs, particularly the Microsoft Office Suite; Excel, Word, PowerPoint (or equivalents if changed by the Company). SAP and/ or Pilgrim Quality Data experience desirable.

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 2024 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)

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