LivaNova

Senior Quality Engineer

LivaNova • $95K — $115K *
Arvada, CO 80004In-Person
Healthcare
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 6-8 years experience in medical device manufacturing, ideally Class II/III
  • Strong proficiency with quality tools like statistical data analysis and flowcharts
  • Knowledge of FDA and ISO regulatory requirements
  • ASQ Certified Quality Engineer is a plus
  • Effective communication skills across different levels of personnel
  • Ability to analyze problems and implement solutions

Responsibilities

  • Support Quality Engineering Management in compliance with Quality Management System and regulations
  • Manage internal and external audits and report on the QMS
  • Analyze data and make disposition decisions on non-conforming products
  • Lead failure investigations and document results for complaints and non-conformities
  • Establish quality control plans according to product risk
  • Coordinate with Engineering on design verification and validation processes
  • Monitor compliance with regulatory requirements and support project communication

Benefits

  • 20% travel requirement
  • Opportunity to work in a regulated environment
  • Professional development through mentoring less experienced staff
  • Engagement with cross-functional teams
  • Conducive work environment accommodating clean room standards
Full Job Description
  • They will support Quality Engineering Management for managing all aspects related to the design and manufacture of the company's products in compliance with the Quality Management System requirements and the regulations of the countries where the franchise distributes and sells products.
  • The position co-operates in managing internal & external audits, interacting with auditing organizations and reporting on the QMS to the company managers.
  • With respect to Nonconforming product handling, they will:
  • Collect and critically analyze data and make disposition decisions on nonconforming products. The Sr. QEs will also provide NC decisions for less experienced QEs to ensure that regulatory and patient risk are minimal.
  • Lead failure investigations and ensure that systematic problem-solving methods are employed and results are properly documented for nonconforming products and complaints.
  • Generate the evaluation of the risk posed by the observed NC on products already distributed (HHE) to determine if Stop Shipment and/or Field Action should be proposed. Ensure the maintenance and update of Risk Management reports to document new issues or increases in severity or occurrence.
  • Own input into the CAPA process and trend data to identify and propose opportunities for CAPA. Support CAPAs either through ownership of the CAPA or as part of a CAPA team. Ownership of the CAPA Process is also a potential for this position. Identify and implement improvements within the QMS.
  • For escalated and larger scope issues, support Supplier Quality with external manufacturers of components, semi-finished and finished products or external service providers in the management of any detected non-conformities.
  • With respect to the Design Control & Production and Process control, they will:
  • Establish product quality control plans commensurate to product risk.
  • Coordinate with Engineering to establish product design verification/validation and process or software validation plans for the change or new product/process development.
  • Review and provide input into process validation planning, protocols, and reports.
  • Performs preliminary review of the change impact assessment to confirm that quality requirements are met.
  • Coordinates investigations for the cause of V&V failures using root cause analysis problem solving methodologies.
  • Identify opportunities for quality improvements in the production area and lead improvement plans or projects.
  • With respect to Analysis of Complaint data and Returned Products, they will:

Provide daily support, as needed for:
  • Complaint evaluations and investigations;
  • Customer-related processes involving use of the device;
  • Provide support to meet Customer Quality complaint and Medical Device Report/Vigilance quality metrics.
  • Develop and maintain effective relationships with internal and external stakeholders to assist customers and drive the resolution of customer complaints.
  • Interface with customers to understand details of issues trending up for all customers or issues specific to a particular account.
  • With Respect to Company Process Improvements as well as Business or Compliance changes, they will:
  • Monitor and maintain compliance with regulatory and company requirements. Understand and implement FDA, ISO 13485, MDSAP, Medical Device Requirements, etc. requirements.
  • Act as the Quality representative to understand and communicate the needs of all quality functions when assigned to large facility, product or process change projects. Act as a leader during these projects and be responsible for communicating the project status and being accountable for the results of the project.
  • Frequently seek and use information from other departments to determine the appropriate response to issues and regulatory impact.
  • Serve as a role model and help to develop the skills and competence of less experienced Quality Engineers, engineers and technicians.
  • Conduct or assist with the review and evaluation of personnel performance for direct reports or when requested otherwise.


Skills and Experience:

  • Excellent communication and presentation skills. Minimum related work experience of 6 to 8 years in medical device manufacturing, preferably Class II/III.
  • Successfully demonstrates an in-depth or breadth of engineering skill(s).
  • Must have proficiency with quality tools such as flowcharts, statistical data analysis, mathematical reasoning
  • Ability to work within a changing environment.
  • Ability to work with a wide variety of personnel on all levels and utilize constructive confrontation while maintaining positive work relationships.
  • ASQ Certified Quality Engineer or other ASQ Certifications is a plus.
  • Knowledge of regulatory requirements (e.g., FDA, ISO) is required for the position.
  • Ability to analyze and problem-solve.
  • Able to communicate across functional lines.
  • Sitting 60-80%, standing & walking 20-40%
  • Repetitive work on computer 80%
  • Must be able to work in a clean room environment and tolerate chemical odors as well as the site and smell of blood.
  • Must be willing to take on related duties as required in support of company and departmental objectives.


Education:
  • Bachelor's Degree in Technical and Scientific disciplines (Physics, Chemistry, Engineering and Biology) or equivalent experience.


Travel Requirements:

20%

About LivaNova

LivaNova is a global medical technology company that develops and manufactures innovative therapeutic solutions for patients with chronic and acute conditions. The company operates in two business units: Cardiac Surgery and Neuromodulation. LivaNova's products include heart-lung machines, oxygenators, autotransfusion systems, and neuromodulation devices. The company was formed in 2015 through the merger of Sorin Group and Cyberonics. LivaNova is headquartered in London, UK, and has operations in more than 100 countries.
Learn more about LivaNova
Size
3,000 employees
Market Cap
$2.9 billion
Industry
Healthcare
Net Income
-$345 million
5 Year Trend
+1.4%
Revenue
$934.2 million
NASDAQ
LIVN
* Ladders Estimates

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