Senior Quality Engineer

LivaNova; Arvada (CO); On-site; USD 90,000 - 130,000; Full time

Job summary

LivaNova is seeking a Senior Quality Engineer to support Quality Engineering management in the design, manufacture, and regulatory compliance of medical devices. The role involves leading investigations into nonconforming products, driving CAPA, and coordinating audits to ensure patient safety and regulatory adherence.

The position requires strong analytical skills, experience in medical device manufacturing (Class II/III preferred), and ASQ QE certification is a plus.

Qualifications

• Bachelor's degree in technical/scientific disciplines (Physics, Chemistry, Engineering, Biology) or equivalent experience.
• Minimum 6–8 years in medical device manufacturing, preferably Class II/III.
• ASQ Certified Quality Engineer or similar certification is a plus.

Responsibilities

• Support Quality Engineering management for design and manufacture in compliance with QMS and regulatory requirements.
• Coordinate internal and external audits and report on QMS to company managers.
• Lead investigations into nonconforming products and CAPA to minimize regulatory and patient risk.
• Develop and maintain risk management documentation and evidence for Stop Shipments or Field Actions when needed.
• Collaborate with suppliers and engineering on design controls, process validation, and changes.

Skills

Quality engineering

Medical device

Statistical data analysis

ASQ Certification

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in engineering/technical field

Tools

Quality tools

CAPA tools

Job description

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.

• 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%

Valuing Different Backgrounds

LivaNova values equality and diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination. Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate's sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.

Notice To Third Party Agencies

Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

Beware Of Job Scams

Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons posing as LivaNova recruiters or employees. The scammers may attempt to solicit confidential, personal information, such as a social security number, or your financial information. LivaNova will never ask for fees prior/during/after the application process, nor will we ask for banking details or personal financial information in return for the assurance of employment. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for "See Open Jobs" on https://www.livanova.com/en-us/careers, and check that all recruitment emails come from an @livanova.com email address.