Supervisor - Repair

Arthrex, Inc Located in: ACI,  California
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Arthrex, Inc Biotechnology Jobs Pharmaceutical Careers
 

JOB DESCRIPTION

Main Objective: Supervises the repair process at ACI, receives, decontaminates, investigates and decides upon the disposition of the returned devices. Essential Duties and Responsibilities: Performs and oversees evaluation and investigation required by complaint procedures on returned material while documenting the results in the complaint program. Follows-up on necessary action with Arthrex Inc, departments. Creates and maintains history reports for trending and analyzes data for further review by appropriate departments to recommend engineering changes or CAPA’s as necessary. Responsible for data entry functions in the complaint program for traceability and future trending to be submitted for review during management review meetings. Performs and oversees returns for repair, prepares the necessary work orders and issues the replacement components as needed in ERP system. Coordinates the required repair work and testing. Follows business policy and guidelines to make warranty determinations and financial decisions. Monitors and maintains the Repair Trade-out pool in ERP system to ensure adequate inventory of product to allow immediate trade-out on customer calls. Oversees the decontamination of incoming repairs using the washer and autoclave, ensuring the process is performed as per defined work instructions and documenting the results as required by the procedure. Initiates any cleaning or maintenance required by the preventive maintenance schedule on the equipment within the department. Supervises, conducts reviews, and makes hiring decisions for team of Repair Technicians. Works primarily unassisted. 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: Bachelor’s degree required. Three years of experience in manufacturing or repair of medical devices or related field preferred. Minimum two years of experience or equivalent in the medical device industry preferred. Minimum two years of supervision experience preferred. Knowledge and Skill Requirements/Specialized Courses and/or Training: Knowledge of FDA Quality System Requirements, ISO 13485 Quality System Requirements, ISO 14971 Risk Management Requirements and GMP, Good Manufacturing Practices. Familiar with Bio-hazardous material handling, storage and disposal. Machine, Tools, and/or Equipment Skills: Various light duty machines and hand tools, strong understanding of Microsoft Word, PowerPoint, Excel and ERP systems. Reasoning Ability: Ability to define problems, troubleshoot assembly problems, collect data, analyzing the variables, drawing a conclusion on the best course of action. Ability to interpret an extensive variety of technical instructions or information contained within engineering prints. 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. The employee is frequently required to sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Potential exposure to Blood Bourne Pathogens, Hepatitis B vaccination series shots recommended. Vision Requirements: Visual acuity necessary to do the job safely and effectively. Specific vision abilities required by this job include close vision work with the aid of a microscope and light source. 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.

CRITICAL REQUIREMENTS

COMPANY INFORMATION

Welcome to Arthrex… we are a global medical device company and leader in new product development and medical education in orthopaedics. With a corporate mission of helping surgeons treat their patients better, Arthrex has pioneered the field of arthroscopy and developed more than 8,500 innovative products and surgical procedures to advance minimally invasive orthopaedics worldwide.

Arthrex continues to experience unprecedented growth and demand for our products throughout the world; however, we remain a privately-held company with a family business culture that is committed to delivering uncompromising quality to the healthcare professionals who use our products, and ultimately, the millions of patients whose lives we impact.

We invite you to learn more about Arthrex and the positive contributions we are making to medicine and the communities we serve.

JOB INFORMATION

Seniority Level:
Management / Supervisory
Function:
 
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation: