Manager QC - Medical Device Manufacturing

Arthrex

About The Position

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 QC Manager, Medical Device Manufacturing for our manufacturing facility in Ave Maria, FL. The QC manager 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™.

Requirements

Bachelor's degree required
5 years of related experience, preferably in a medical device manufacturing environment in quality systems, quality control, and/or quality engineering
3+ years supervisory experience required
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.
Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), SAP.
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.
Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
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.
The employee must occasionally lift and/or move up to 10 pounds.
To bend frequently and lift 50-70 lbs on a regular basis.
Visual acuity necessary to do the job safely and effectively.
Specific vision abilities required by this job include close vision.

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
Ensure compliance within functional area and support the compliance objectives of the organization as a whole.