Arthrex Job - 39173808 | CareerArc
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Company: Arthrex
Location: Ave Maria, FL
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

Requisition ID: 48505 Title: Manager - QC Division: Arthrex Manufacturing Inc (US02) Location: Ave Maria, FL

 

 

Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively seeking a Quality Control Manager to oversee, manage and provide direction to the QC department that will effectively and profitably meet or exceed the internal and /or external client's expectations by providing superior quality products and service.  Excellent communications and analytical skills, strong technical project management skills and a Bachelors' degree will be essential for this position. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

 

Essential Duties and Responsibilities:

  • Manages and directs the efforts of the Quality Control Inspectors and Quality Control Supervisors.
  • Reviews and coordinates intradepartmental approval of internal and externally generated NCRs, CAPAs, Deviations, and other Quality System inputs using established procedures and work instructions. 
  • Responsible for identifying,, communicating, and documenting discrepant incoming articles to Supplier Management and Vendors to correct according to procedure, including  coordinating MRB efforts
  • Responsible for assuring the integrity and completeness of Device History Files
  • Responsible for staffing, positioning, hiring and disciplinary action (as necessary) the QC department
  • Responsible for maintaining and equipping the inspection department to meet the needs of tests and inspections required by new and modified products
  • Responsible for assuring First Article Inspections are completed for all new/modified articles
  • Responsible for assuring QC Inspectors are properly trained in all inspection equipment and techniques, procedures and SOPs
  • Responsible for maintaining efficient work flow, work assignments and throughput standards for incoming articles
  • Responsible for assuring the effectiveness and implementation of the calibration program
  • Responsible for defining, establishing, and implementing raw material, in-process, and finished quality sampling and inspection plans to include the use of statistical quality/process control where applicable
  • In collaboration with Supplier Quality Assurance, responsible for obtaining  corrective actions  from Vendors in relation to incoming article nonconformance in accordance with established procedures and SOPs
  • Responsible for the review and approval of inspection SOPs and quality system documents that pertain to the Quality Control function.
  • Strong communication, collaboration, and teamwork with other departments to ensure the effective execution of the quality system

Incidental Duties:

The above statements describe the general nature and level of work being performed in this job.  They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

 

Education and Experience:

Bachelors Degree required.

5 years previous quality management experience required, preferably in a medical device manufacturing environment.

 

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

Knowledge of testing equipment and applicable national standards relating to testing (i.e. ASTM standards, etc).  Familiarity in operating all test and inspection equipment used in Quality Control. Familiarity with applicable federal, military, FDA, ISO and EN specifications.

 

Machine, Tools, and/or Equipment Skills:

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

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.


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