VP Software Engineering at GM Financial responsible for technology implementation strategy and leading product teams in Agile environment. Championing technology modernization and driving operational excellence.
About the role
- Principal Quality Engineer leading post-market quality and compliance for infusion systems and temperature management products. Responsible for product quality improvements and regulatory compliance solutions.
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
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
- Master’s degree preferred
- Medical device experience is required
- 10+ years of experience is required
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
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