Endologix, Inc

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Quality Systems Director

Quality Systems Director

Job ID 
2017-1746
Location 
US-CA-Irvine

More information about this job

Overview

Endologix develops and manufactures the latest innovations in endovascular aneurysm repair and sealing. We are a fast-moving, high energy organization. Employees are offered development opportunities and new responsibilities that might have taken them significantly more time in other organizations. Our commitment is to promise the development and refinement of skills while providing competitive compensation and benefits.

 

Leads the quality system organization across all Endologix sites.  Responsible for providing leadership in establishing, implementing, and maintaining Quality System processes and documentation in compliance with domestic and international Regulatory and Quality standards by performing the following duties personally or through subordinates.

 

 

Responsibilities

  • Establishes and maintains Quality System programs including Internal Audits, CAPA, document control and archiving, change control, software quality and quality systems training; manages these functions acros sites (Irvine, Santa Rosa, Rosmalen)
  • Ensures that Quality System processes are compliant with applicable domestic and international Regulatory and Quality standards.
  • Ensures that company employees are trained on applicable regulations, both domestic and international regulations and standards. 
  • Serves as Business Owner for QMS System (Trackwise) and change control/document control system (Master Control)
  • Schedules, conducts and/or supervises internal and cGMP audits. 
  • Acts as advisor to subordinate staff to help meet established schedules or resolve issues.
  • Maintains information in various compliance databases and produces reports as needed.
  • Provides reports on the status of the Quality System to executive management by preparation of Management Review presentations.
  •  Leads preparation and management for external regulatory inspection activities.  Communicates with FDA and International ministry of health officials as assigned. 
  • Maintains an up-to-date knowledge in applicable domestic and international regulations and standards, as well as, company products and process technologies.
  • Responsible for ensuring that subordinates follow all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
  • Identifies and reports risk trends to management.
  • Perform other duties as assigned by supervisor.

Qualifications

  • Demonstrated an understanding of and ability to interpret regulations and guidelines governing medical devices including QSR’s, ISO 13485, CMDR, MDD and JPAL.
  • Bachelor's degree in a scientific discipline or equivalent.
  • Strong communication and organization skills required.
  • Experience with problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
  • Good judgment skills within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Works independently leading the quality systems department

 

Education:

  • Bachelor's degree in Engineering from a four-year college or university; or related major preferred; Masters of Science (MS) degree in or Master’s degree related to  preferred
  • Equivalent experience in medical device quality leadership roles

Experience:

  • 15 years of Quality Systems experience with a Bachelor’s degree
  • 12 years of Quality Systems experience with a with a Master's degree
  • 20 years experience in medical device quality without a degree

 

Specific Skills, Knowledge & Behaviors

 

(To perform the job successfully, an individual should demonstrate the following competencies):

 

Core Competencies:

·         Customer Focus: Solicit and apply feedback from internal and external customers; Understand customers’ current and future expectations; Respond promptly to customer needs.

·         Innovation: Develop and champion unique ideas and solutions; Find new ways to use technology more effectively; Promote continuous learning.

·         Interdependent Partnering: Contribute to a productive and cooperative atmosphere; Show commitment to team objectives; Contribute own fair share of effort.

·         Master Complexity: Competently handle day-to-day work challenges; Thrive in uncertain circumstances; Adapt to changes in the work environment; Manage multiple tasks and competing demands; Change approach or method to best fit the situation.

·         Organizational & People Development: Function as both team player and leader; Provide informal feedback; Challenge the status quo; Strive for continuous professional development; Recognize the contributions of others; Set and achieve challenging goals.

·         Spoken Communication: Speak clearly and concisely; Listen carefully and seek clarification; Deliver effective presentations.

·         Written Communication: Write clearly and informatively; Create documents that are complete and accurate.

·         Commitment: Strive to attain quality results on time; Convey a sense of urgency and drive issues to closure; Earn a reputation for reliability and dependability.

·         Decisions: Make timely and sound decisions; Take risks and manage them intelligently.

·         Problem Solving: Proactively seek solutions; Gather and analyze information systematically; Develop alternative solutions; Think analytically and act decisively.

·         Diversity: Respond with sensitivity to people of diverse perspectives, ideas, backgrounds, lifestyles and ages; Foster open communication and respect for the individual.

 

Equipment Use & Abilities Required:

 

·         Equipment Use:   Copy machines, fax machines, calculators and personal computers and computer terminals.

·         Computer Skills: Software proficiency in Microsoft Office Suite.

·         Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, legal documents or governmental regulations.   Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

·         Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

·         Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form

 

 

WORK ENVIRONMENT & PHYSICAL DEMANDS OF THE JOB:

 

The noise level in the work environment is usually quiet. While performing the duties of this job, the employee is regularly required to sit; use hands and fingers; talk or hear. The employee is occasionally required to reach with hands and arms and to move within and between the buildings. A computer terminal is used to access, input, and retrieve data. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision.

 

Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

                                            

If you are a qualified individual with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access our career center as a result of your disability. To request an accommodation, contact a Human Resources Representative at Endologix Global Headquarters at 949-595-7200 or Endologix Santa Rosa Facility at 707-543-8800