Manager QC; Medical Device Manufacturing

Title: Manager QC (Medical Device Manufacturing)

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 a Manager – Quality Control for our Ave Maria Manufacturing site who is responsible for managing, improving, and maintaining the manufacturing Quality Control activities to ensure products are manufactured to specifications that meet safety and efficacy expectations.

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

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

3 years of people leadership experience required

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.

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.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear.…