1st shift and 2nd shift schedule- 10 hr shift/4 days per week with Saturday rotation included.
Main Objective:
To oversee, manage and provide direction to the QC Inspection department that will effectively and profitably meet or exceed the expectations by providing superior quality products and service.
Essential Duties and Responsibilities:
Supervises and directs the efforts of the Quality Control Inspectors for a specific work shift.
Schedule work assignments, assign tasks, train new employees and demonstrate proper operation of equipment. Observe work as it is performed to ensure it is done properly and safely.
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.
Confur with supervisors from other departments to coordinate operations and activities and meets with managers or subordinates to resolve issues.
Responsible for interfacing with all departments and coordinating MRB efforts.
Reviews, and coordinates intradepartmental approval of internal generated nonconformance reports and deviations, maintain log of same.
Responsible for assuring the integrity and completeness of Device History Files
Responsible for identifying the tool and equipment needs of the inspection department to properly and adequately perform tests and inspections required by current and new products, and reporting those needs to Quality Control Management.
Responsible for the review and approval of inspection SOPs and quality system documents that pertain to the Quality Control function.
Evaluate employees through performance reviews.
Other duties as assigned
Requirements
Education and Experience:
Associates Degree or equivalent plus trade school education in product testing or equivalent on the job training. At least 10 years experience in a Quality Control or Quality Assurance position. Five years direct management experience in a medical device company is preferred.
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), QAD.
EOE D/F/W
Arthrex - 10 months ago
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