Endologix, Inc

Staff Software Quality Engineer

Job ID
2018-1800
Location
US-CA-Irvine
Category
Quality

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.

 

 

Responsible for leading and executing the Software Quality Engineering program, and supporting cross-functional departments to provide the organization with compliant computer systems that support business requirements and processes globally.

Responsibilities

  • Develop, maintain, and improve software quality processes and procedures to assure compliance with worldwide regulatory requirements.
  • Assuring all GxP computerized systems have been validated to reflect Endologix intended usage of the system.
  • Assurance that all computerized systems have been validated per appropriate Endologix procedures and processes.
  • Partnering with IT to assure all Endologix systems have been identified, assessed and controlled for intended company use.
  • In conjunction with IT management, evaluate and determine strategic plan for implementing computer systems globally following the GAMP5 SDLC approach.
  • Participate in software validation planning, development and execution activities as required

Qualifications

 

Minimum Education:

 

Bachelor’s degree in a scientific/engineering discipline required. Master’s degree desired

 

Minimum Experience:

• Minimum of eight years’ experience, preferably within medical devices,
• Experience in software validation within a regulated environment is required.
• Strong time management skills, good documentation practices and communication skills are required.
• Direct and matrixed supervisory experience, strategic thinking and problem solving capability is preferred.
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Specific Skills, Knowledge & Behaviors
(To perform the job successfully, an individual should demonstrate the following competencies):

 

• Thorough understanding of FDA and ISO regulations and software metrics.
• Ability to interpret regulations and guidelines governing medical devices including but not limited to, QSR’s, ISO 13485, ISO 14971, JPAL, CMDR, ANVISA and MDD.
• Self-starter and works independently with minimum supervision

 

CORE COMPETENCIES:


1. Customer Focus: Solicit and apply feedback from internal and external customers; Understand customers’ current and future expectations; Respond promptly to customer needs.
2. Innovation: Develop and champion unique ideas and solutions; Find new ways to use technology more effectively; Promote continuous learning.
3. Interdependent Partnering: Contribute to a productive and cooperative atmosphere; Show commitment to team objectives; Contribute own fair share of effort.
4. 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.
5. 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.
6. Spoken Communication: Speak clearly and concisely; Listen carefully and seek clarification; Deliver effective presentations.
7. Written Communication: Write clearly and informatively; Create documents that are complete and accurate.
8. 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.
9. Decisions: Make timely and sound decisions; Take risks and manage them intelligently.
10. Problem Solving: Proactively seek solutions; Gather and analyze information systematically; Develop alternative solutions; Think analytically and act decisively.
11. 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:

 

1. Equipment Use: Copy machines, fax machines, calculators and personal computers and computer terminals.
2. Computer Skills: Software proficiency in Microsoft Office Suite.
3. Language Skills: Strong communication and organizational skills to effectively manage and get results with external suppliers. Ability to form strong cooperative working relationships with internal and external partners
4. Reasoning Ability: Good judgment skills within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Flexibility to handle multiple tasks and meet timelines

WORK ENVIRONMENT & PHYSICAL DEMANDS OF THE JOB:

 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this 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 stand; walk, and sit for extended periods of time.

 

 

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

 

 

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