Principal Engineer, Quality

ICU Medical • Lake Forest, IL

3h

About The Position

Reporting to the Quality Director, the Principal Quality Engineer will lead Post Market Quality and Compliance support for Infusion Systems and Temperature Management product lines. This individual will identify, own, and drive product quality improvements through both reactive and proactive product performance monitoring and escalation of product Quality issues via the Corrective and Preventive Action (CAPA) and Post Market Risk Assessment (PMRA) processes. The Principal Quality Engineer works with Medical Affairs, Regulatory, Risk Management, Engineering, R&D, Manufacturing, Commercial and other functions to lead the escalation of product issues to Market Action (MA) as required. This individual also shares post-production product performance feedback with Sustaining Engineering and Design Assurance to drive continuous product improvements.

Requirements

• Strong knowledge and experience in the application of global medical device regulations and standards, including 21 CFR 820/803/806, ISO 13485, ISO 14971, and IEC 60601
• Significant knowledge and experience in Failure Mode Analysis and Risk Management
• Expert in Quality Tools used in Quality Engineering investigations and Root Cause Analysis
• Ability to take a systems approach to understand the interactions between device components (i.e. hardware, software, consumables) when investigating product Quality issues
• Knowledgeable and experienced in applying statistical analysis to large/complex data sets
• A strong communicator experienced in interacting with auditors, customers and senior leaders
• A collaborative influencer who leads through change to drive product/process improvement
• Must be at least 18 years of age
• Bachelor’s degree in engineering (e.g., Electrical, Mechanical, Biomedical) or related STEM field from an accredited college or university is required
• Medical device experience is required
• 10+ years of experience is required

Nice To Haves

• Master’s degree preferred

Responsibilities

• Leads Post Market Risk Assessments of product issues to assess the need for Market Action
• Leads product performance investigations via failure analysis in individual complaints or through the evaluation of product-related trends (e.g., complaint, NCMR, SCAR)
• Leads the drafting of responses to regulatory enquiries associated with product performance
• Leads or participates in cross functional Complaint and CAPA Review Boards
• Owns or support product related CAPAs, as required
• Leads or participates in Quality projects and product risk file reviews, as required
• Leads and mentors, ensuring requirements associated with regulations and standards are met
• Effectively utilizes Quality tools to communicate recommendations to stakeholders
• Ensure readiness for any potential internal and/or external audits and inspections

Benefits

• Competitive financial benefits, including a generous 401(k) match and (for eligible roles) our Annual Incentive Plan
• A wide range of benefit options at affordable rates
• Additional perks to assist employees with their work-life effectiveness, such as Paid Time Off, Company Holidays, and Tuition Reimbursement

What This Job Offers

• Job Type: Full-time
• Career Level: Senior