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Quality Engineering Manager in Santa Barbara, CA ,  at Arthrex

Date Posted: 10/16/2018

Job Snapshot

Job Description


Requisition ID:
40901
Title:
Quality Engineering Manager
Division:
Arthrex, Inc.
Location:
Santa Barbara, CA

Main Objective:

Responsible for leading quality engineering team for design, development transfer, QA manufacturing and post-market surveillance of FDA Class I and II, EU Class I, IIa, IIb and III medical devices in the achievement of company goals.

Essential Duties and Responsibilities:

  1. Manages Quality Supervisors, Quality Engineers and Quality Assurance Technicians assigned to design and operation support activities to provide timely and efficient flow of services and projects.
  2. Maintains a leading edge understanding of the quality processes required in designing, manufacturing and post market performance of arthroscopic, orthopedic devices and capital equipment in order to find new and novel opportunities to improve product quality and reduce cost.
  3. Effectively implements enhancements and improvements as necessary to ensure maintenance of state-of-the-art processes and compliance to pertinent international standards and regulatory requirement, e.g., ISO 13485, 21 CFR 820, European MDR, etc...
  4. Ensures effective implementation of reference standards in the execution of quality-related actives, e.g., ISO 14971, IEC 62366, etc.
  5. Fosters consistent quality input and partners with design & manufacturing engineering and operations to support new product development and sustaining engineering activities
  6. Provides Quality Engineering project oversight and management, including initiating and leading cross-functional teams.
  7. Generates and oversees the development quality timelines for new product introduction and sustaining quality engineering activities.
  8. Oversees timely and thorough investigation, root-cause analysis, completion, and effectiveness review of product design-related corrective and preventive actions (CAPA);
  9. Leads hiring and developing the quality engineering team by actively coaching and providing career development assistance to team members;
  10. Develops future leaders by effective selection, mentorship, and development activities;
  11. Reports progress and status of projects on a timely basis with emphasis on reporting results to upper management.
  12. Uses appropriate statistical tools/methodologies to drive quality improvements in product lines.

    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 of Science Degree in Engineering required.
  • Minimum seven years Medical Device Industry experience with a minimum of 3 years supervisory or management experience.

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

  • Working knowledge of ISO and FDA quality requirements.
  • Manufacturing process knowledge.
  • Technical knowledge in development methodologies, design quality analysis, and project implementation of Electro-Mechanical Medical Devices and supporting accessories.
  • Proficiency in assessing manufacturing quality requirements of new product ideas

Machine, Tools, and/or Equipment Skills:

PC, Microsoft Office, ERP software

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.  The employee is frequently required 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. 

Vision Requirements:

Visual acuity necessary to do the job safely and effectively. 

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The area that this job is performed in is a general office or open cubicle/workstation and manufacturing environment.  The noise level in the work environment is usually moderate.

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.