Quality Engineer (On-site)

LivaNova PLC

Arvada (CO)

On-site

USD 67,500 - 82,500

Full time

14 days+

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Benefits offered by this job

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

Job summary

LivaNova PLC is seeking a Quality Engineer in Arvada, CO to ensure compliance with quality management systems in medical device manufacturing. The role involves analyzing nonconforming products, leading investigations, and enhancing production quality.

Qualified candidates should have a Bachelor's degree and experience in medical devices. Benefits include health insurance, a 401K plan, and flexible work schedules.

Qualifications

Minimum 1–3 years in Class II/III medical device manufacturing.
Knowledge of FDA, ISO 13485 regulatory requirements.
Proficiency with quality tools.

Responsibilities

Collect and analyze data on nonconforming products.
Lead investigations on product failures.
Manage complaint handling activities.

Skills

Flowcharts

Statistical data analysis

Mathematical reasoning

Problem-solving

Communication skills

CAPA experience

Education

Bachelor’s Degree in Technical and Scientific disciplines

Job description

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 ensure 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. He/she evaluates situations of non‑conforming products, collects and analyzes data to propose product disposition and CAPA’s 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. This is an on‑site position located at our office in Arvada, CO.

General Responsibilities

With respect to Nonconforming product handling:
- 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.
With respect to Design Control & Production and Process control:
- Establish 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.
With respect to Analysis of Complaint data and Returned Products:
- Daily management of the assigned complaint handling activities.
- Providing daily support, as needed for 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.
- Respects the Health and Safety Regulations in his/her field of competence.

Performs other duties as may be required by their manager.

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).

Travel Requirements

Occasional travel may be required.

Pay Transparency

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

Employee benefits include: