Quality Engineer (On-site)

As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow—because at LivaNova, we don’t just treat conditions — we aspire to alter the course of lives.

About the Role

With a high degree of autonomy, this role performs quality work of a broad nature to achieve successful outcomes of departmental and company objectives. The Quality Engineer will contribute to ensuring that production and process control activities are conducted in compliance with the company quality management system and the international regulations governing medical device manufacturing and distribution. This position evaluates non-conforming products, collects and analyzes data to propose product disposition and CAPAs to address quality issues. It also analyzes product complaint returns and determines actions required to prevent recurrence or communicates the information to the manufacturer or creates process improvements. This is an on-site position located in Arvada, CO.

Responsibilities

• Supports Quality Management for executing quality engineering activities related to the design and manufacture of products in compliance with the Quality Management System requirements and regulations of the countries where the franchise distributes and sells products.
• Nonconforming Product Handling:
  • Collect and critically analyze data and take disposition decisions on nonconforming products identified in production.
  • Lead investigations to identify the causes of components/product failures (nonconforming products from production and complaints).
  • Generate evaluations of the risk posed by observed nonconformities on products already distributed (Health Hazard Evaluation) to help management determine if Stop Shipment and/or Field Action is initiated.
  • Lead CAPA projects and trend data to identify opportunities for future CAPA.
  • Support external manufacturers of semi-finished and finished products in managing detected nonconformities.
  • Notify suppliers of non-conformance related to purchased material and evaluate corrective actions consistency versus internal controls.
• Design Control & Production and Process Control:
  • Establish product quality control inspections/plans.
  • Review process validation planning, protocols, and reports.
  • Perform preliminary review of change impact assessments to confirm quality requirements are met.
  • Establish and maintain Risk Management files.
  • Collaborate in investigations into the cause of V&V failures.
  • Identify opportunities for quality improvements in the production area and lead improvement plans.
• Analysis of Complaint Data and Returned Products:
  • Daily management of assigned complaint handling activities.
  • Provide support for customer-related processes involving device use, complaint evaluations, and investigations.
  • Ensure timely analysis to meet Customer Quality complaint and MDR reporting quality metrics.
  • Lead effective meetings, conduct presentations, and establish quality records.
  • Develop effective relationships with internal personnel and external stakeholders to assist customers and drive resolution of complaints.
• Respect Health and Safety Regulations in the field of competence.
• Perform other duties as required by their manager.

Requirements

• Minimum related work experience of 1-3 years in Class II/III medical device manufacturing or related regulatory industry.
• Knowledge of regulatory requirements (e.g., FDA, ISO 13485) as required for the position. Experience with MDSAP and Medical Device Requirements is a plus.
• Proficiency with quality tools such as flowcharts, statistical data analysis, and mathematical reasoning.
• Ability to analyze and problem-solve with CAPA experience.
• Ability to work within a changing environment and with a wide variety of personnel on all levels.
• ASQ Certified Quality Engineer or other ASQ Certifications is a plus.
• Excellent communication (written and verbal) and presentation skills.
• Sitting 60-80%, standing & walking 20-40%.
• Repetitive work on computer 80%.
• Oral and written comprehension.
• Ability to work in a clean room environment and tolerate chemical odors.
• Ability to work in a lab environment and tolerate the smell and sight of blood.
• Willingness to take on related duties as required in support of company and departmental objectives.

Qualifications

• Bachelor’s Degree in Technical and Scientific disciplines (Engineering, Physics, Chemistry, and Biology).

Travel

Occasional travel may be required.

Pay

A reasonable estimate of the annual base salary for this position is $75,000 + discretionary annual bonus. Pay ranges may vary by location.

Benefits

• Health benefits – Medical, Dental, Vision
• Personal and Vacation Time
• Retirement & Savings Plan (401K)
• Employee Stock Purchase Plan
• Training & Education Assistance
• Bonus Referral Program
• Service Awards
• Employee Recognition Program
• Flexible Work Schedules