Quality Engineer

Summary

LivaNova is a global medtech company committed to changing lives through innovative healthcare solutions. The Quality Engineer will ensure compliance with quality management systems and international regulations, evaluate non-conforming products, and lead quality improvement initiatives.

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
• 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

• 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
• 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
• 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
• Bachelor's Degree in Technical and Scientific disciplines (Engineering, Physics, Chemistry, and Biology)
• Experience with MDSAP and Medical Device Requirements is a plus
• ASQ Certified Quality Engineer or other ASQ Certifications is a plus

Qualifications

Must Haves

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

Nice to Haves

• Experience with MDSAP and Medical Device Requirements is a plus
• ASQ Certified Quality Engineer or other ASQ Certifications is a plus

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