Quality Engineer

LivaNova; Arvada (CO); On-site; USD 85,000 - 95,000; Full time

Job summary

LivaNova is seeking a Quality Engineer in Arvada, Colorado, to ensure compliance with its quality management system for medical devices. This role involves evaluating non-conforming products, leading CAPA projects, and improving product quality.

The ideal candidate should possess a Bachelor's Degree in a technical field and have 1-3 years of experience in the medical device industry, along with knowledge of FDA and ISO standards. The salary range is $85,000-$95,000, plus an annual bonus.

Qualifications

• Minimum 1-3 years of experience in Class II/III medical device manufacturing.
• Knowledge of FDA and ISO 13485 regulations.
• Experience with MDSAP and regulatory requirements is a plus.

Responsibilities

• Evaluate non-conforming products and propose CAPA.
• Analyze product complaints for improvements.
• Lead CAPA projects and data trend analysis.

Skills

Quality tools proficiency

Regulatory knowledge (FDA, ISO 13485)

Data analysis

Problem-solving ability

Communication skills

Education

Bachelor’s Degree in Technical and Scientific disciplines

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.

Position Summary

With a high degree of autonomy, the person will perform 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.

Evaluates situations of non-conforming products, collects and analyzes data to propose product disposition and CAPA to address quality issues. This position also analyzes product complaint returns and determines actions required to prevent recurrence or communicates the information to the manufacturer or creates process improvements.

General Responsibilities

• Collect and critically analyze data and take disposition decisions on nonconforming products identified in production.
• Lead proper investigation to identify the causes of components / product failures (nonconforming products from production and complaints)
• Generate the evaluation of the risk posed by the observed NC 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.
• Whenever applicable support external manufacturers of semi-finished and finished products in the management of any detected nonconformities.
• May notify suppliers of any non-conformance related to purchased material and evaluate corrective actions consistency versus internal controls.
• Establishes product quality control inspections/plans.
• Reviews process validation planning, protocols and reports.
• Perform preliminary review of the change impact assessment to confirm that quality requirements are met.
• Establish and maintain Risk Management files.
• Collaborates in the investigations into the cause of V&V failures.
• Identify opportunities for quality improvements in the production area and lead improvement plans.
• Daily management of the assigned complaint handling activities.
• Customer-related processes involving use of the device.
• Complaint evaluations and investigations.
• Provides support for timely analysis to meet Customer Quality complaint and MDR reporting quality metrics.
• Leads effective meetings, conducts presentations, establishes quality records.
• Develops effective relationships with internal personnel and external stakeholders to assist customers and drive the resolution of customer complaints.

Skills And Experience

• 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.
• Must have proficiency with quality tools such as flowcharts, statistical data analysis, mathematical reasoning.
• Ability to analyze and problem-solve with CAPA experience.
• Ability to work within a changing environment.
• Ability to work with a wide variety of personnel on all levels and utilize constructive confrontation.
• ASQ Certified Quality Engineer or other ASQ Certifications is a plus.
• Excellent communication (written and verbal) and presentation skills.
• Able to communicate across functional lines.
• Sitting 60-80%, standing & walking 20-40%.
• Repetitive work on computer 80%.
• Oral and written comprehension.
• Must be able to work in a clean room environment and tolerate chemical odors.
• Must be able to work in a lab environment and tolerate the smell and sight 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 (Engineering, Physics, Chemistry, and Biology).

Pay Transparency

$85,000-$95,000 salary + annual bonus incentive.

Travel Requirements

Occasional travel may be required.

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.