Job Description:

Requisition ID:	49239
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.  Experience in Quality Control, Quality Assurance and/or Production Management in a medical device, pharmaceutical, or biotechnology company is a plus. Excellent communications and analytical skills, strong leadership 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:

• Leads, manages, and develops/coaches Quality Control staff to monitor and continually improve personnel performance and product quality inspection methods and effectiveness.


• Proactively drives the evaluation, monitoring, and continuous improvement of quality control inspection methods and efficiency opportunities.


• Reviews and coordinates intradepartmental approval of internal and externally generated NCRs, CAPAs, Deviations, and other Quality System inputs using established procedures and work instructions. 


• Ensures the nonconforming material identified from receiving, in-process, and finished device acceptance is identified, documented, and communicated to affected parties for timely and effective resolution


• Ensures quality control inspection plans, tests and methods are adequately developed (including test/inspection equipment), implemented, maintained and utilize statistical methodology, where appropriate, for receiving, in-process, and finished device acceptance.


• Responsible for assuring First Article Inspections are completed for all new/modified articles


• Responsible for assuring employees are properly trained


• Responsible for maintaining and reporting departmental process efficiency goals, work assignments and throughput standards


• Responsible for the review and approval of applicable Quality System documents.


• 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, preferably in Engineering or Science


• 5 years of related experience required, preferably in a medical device manufacturing environment in quality systems, quality control, and/or quality engineering


• Previous experience supervising other quality control/assurance professionals preferred

 

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

Strong leadership skills and ability to collaborate effectively with team members and stakeholders. Familiarity with quality control concepts, test methods, equipment and applicable national standards relating to testing (i.e. ASTM standards, etc).  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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