Quality Engineer; On-site Job Greeley area,Colorado USA,Quality Assurance

Position: Quality Engineer (On-site)

Overview

Quality Engineer at Liva Nova will contribute to ensure that production and process control activities are conducted in compliance with the quality management system and international regulations governing medical device manufacturing and distribution.

Responsibilities

With respect to Nonconforming product handling, lead activities including data collection and disposition decisions on nonconforming products identified in production; lead investigations to identify causes of components/product failures; evaluate risk posed by observed nonconformities (Health Hazard Evaluation) to determine if Stop Shipment and/or Field Action is initiated; lead CAPA projects and trend data to identify opportunities for improvement; support external manufacturers of semi-finished and finished products in managing detected nonconformities when applicable;

notify suppliers of non-conformances related to purchased material and evaluate corrective actions for consistency with internal controls.

With respect to Design Control & Production and Process Control, establish product quality control inspections/plans; review process validation planning, protocols and reports; perform preliminary reviews of change impact assessments to ensure 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.

Additional

Responsibilities

Daily management of the assigned complaint handling activities; provide daily support for customer-related processes involving device use; conduct complaint evaluations and investigations; support 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 and external stakeholders to assist customers and drive 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 is a plus.
Proficiency with quality tools such as flowcharts, statistical data analysis, and mathematical reasoning; CAPA experience.
Ability to work in a changing environment and with a wide variety of personnel; strong communication across functional lines.
ASQ Certified Quality Engineer or other ASQ certifications is a plus; excellent written and verbal communication and presentation skills.
Physical requirements:

sitting 60-80%, standing 20-40%, repetitive computer work 80%; ability to work in clean room and lab environments with tolerances for chemical odors and blood.

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

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

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