Endologix, Inc

Senior Manager of Quality Operations

Job ID
2017-1787
US-CA-Santa Rosa
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.

 

Primary responsibilities will be to lead, manage, plan and execute the Quality Operations activities to support the manufacturing of various aortic vascular treatment devices. Plan and implement Quality Operations programs designed to ensure continuous production of products consistent with established standards by performing the duties listed below.

Responsibilities

  • Ensure that activities are in compliance with the respective areas that are applicable from FDA GMP/GLP, ISO 13485, CMDR, CMDCAS, Medical Device Directive, Japan (ordinance 210, GMP, GPMI, Pharmaceutical Affairs Law) and other national and international standards as necessary.
  • Ensure adequate quality engineering support for manufacturing. Manage and address product related issues arising in the manufacturing clean rooms and assure elements such as NCR, CAPA, audits and scrap are being used properly.
  • Oversee Receiving Inspection and Final Release areas. Advise on maintenance of inspection and testing procedures for raw materials, packaging materials, components and finished products.
  • Manage engineering team during investigations to determine root cause. Assign and ensure completion of corrective and preventive actions. Ensure timely completion of investigations to maintain customer service levels.
  • Manage reporting and trend analyses for non-conformance incidences.
  • Partner with Manufacturing/Operations, R&D, Supply Chain and other functions to ensure quality assurance and engineering methods.
  • Maintain high level of quality products and processes from development through manufacturing in accordance with applicable requirements.
  • Apply quality engineering tools to drive methodical and data-based approaches to products and process improvements, applying where possible new technologies and methods.
  • Utilize quality tools including six sigma methodology, lean principles, advanced statistics, reliability engineering, design assurance techniques, and other proven tools.
  • Support sustaining projects, including qualification of supplier changes, process changes, and inspection improvements, and support new product introductions into manufacturing.
  • Advise manufacturing on equipment qualification, process validation, and product line design/modifications requirements.
  • Work with Facilities to establish and maintain effective environmental monitoring systems.
  • Review and update the product risk analysis documents to ensure risk controls adequately address and minimize potential patient safety risks in terms of process variation.
  • Participate in quality system audits by maintaining familiarity with applicable regulations and company procedures.
  • Promote and organize training activities related to product quality, cost, reliability, and regulatory compliance.
  • Maintain an up‑to‑date knowledge in the techniques of Quality Assurance/Quality Control and in the company products and process technologies.
  • Develop systems for the identification, analysis, correction, and prevention of quality issues.
  • Work with Quality and the Operations Team to develop a culture of accountability, empowerment, continuous improvement, customer focus, collaboration, and celebration of good work, involvement and development of all people within the team.
  • Instill a sense of urgency to ensure goals are met in a timely manner while meeting regulatory and quality standards and customer requirements.
  • Communicate effectively to all levels of an organization.
  • Maintain an up‑to‑date knowledge in the techniques of Quality Assurance/Quality Control and in the company products and process technologies.

 

Supervisor Core Competencies:

Leading Change: Develops and implements strategies and approaches for leading and managing organizational transformation at individual , functional, and enterprise levels, and influences change where needed

Inspiring the Workforce: A compelling storyteller, motivates and engages employees at individual and group levels towards results

Selecting & Developing Talent: Assesses, selects, coaches, mentors, provides constructive feedback, empowers and develops the workforce at individual and group levels

Strategic thinking: Creates the vision and direction, assesses priorities, understands , analyzes, and acts upon drivers of business and operational success at a departmental, functional, and/or enterprise level

Global & systems thinking: Understands and embraces global nuances, leads across functions and geographies, builds alignment across diverse groups , and looks at the company holistically

External Industry Leadership & Knowledge: Connects with and influences health care and/or functional industry regulatory and government organizations, and understands external industry factors that impact the company and products

Continuous Improvement: Leverages best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learning and building new capabilities into self and team

Problem Solving & Problem Prevention: Uses strong problem solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention

Accountability: Drives and focuses on results, takes initiative without direction, takes broad ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility

 

Core Competencies:

Interpersonal Effectiveness: Actively seeks to understand perspectives and interpersonal needs and expectations of others at all levels, builds self awareness, flexes personal style appropriately, and works through conflicts constructively and appropriately

Communication: Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills

Collaboration & Teamwork: Actively works together with formal and informal team members to build relationships and achieve team goals

Prioritization: Effectively prioritizes work to ensure timely completion of work within scope

Global & Systems Thinking: Continuously seeks to learn about and embrace global nuances, works across functions and geographies, seeks to align with diverse groups, and seeks to understand interdependencies and impacts of actions across functions and the company

Technical Expertise: Continuously builds functional and technical expertise, and pro-actively applies that technical expertise in progressively broader scope

Continuous Improvement: Learns and uses best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learning and building new capabilities into self

Problem Solving & Problem Prevention: Learns and uses strong problem solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention

Accountability: Focuses on results, takes initiative without direction, takes ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility

Qualifications

Minimum 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 medical device field preferred; PhD degree related to medical device field

Minimum Experience:

  • Twelve years with a Bachelor’s degree and a Master’s degree preferred

  • Ten years with a PhD

 

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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