Cardinal Health · 8 hours ago
Principal Supplier Quality Engineer
USA
Full-time
Remote
Mid, Senior Level, Lead/Staff
$80K/yr - $114K/yr
4+ years exp
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Responsibilities
Adhere to Good Manufacturing Principles (GMPs) based Quality Management Systems requirements for medical devices and medicinal products
Identify and lead implementation of preventive and corrective actions via CAPAs, audits, NCMRs, and complaint handling systems
Lead implementation of Supplier Change Requests and utilize Production Part Approval Process (PPAP)
Key contributor on NPD (New Product Development) projects, ensuring rigorous performance and APQP deliverables (CTQ, PFMEA, control plan, GRR, FAI, IQ/OQ/PQ, PPA, etc.), in collaboration with Procurement, Manufacturing and R&D
Ensure supplier quality systems adhere to all applicable regulations and standards
Ability to lead and influence cross-functional teams to drive reduction in patient safety risk and greater levels of regulatory compliance
Apply experience and knowledge of MDD (Medical Device Directive), EU-MDR (Medical Device Regulations), ISO 13485 (Quality Management Systems), Pharmaceutical guidelines, FDA, cGMP, and Risk Management (ISO 14971) to instill a culture dedicated to ensuring patient safety and sustained regulatory compliance
Qualification
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Required
4-8 years of experience
Bachelor's degree in related field, or equivalent work experience
Adhere to Good Manufacturing Principles (GMPs) based Quality Management Systems requirements for medical devices and medicinal products
Identify and lead implementation of preventive and corrective actions via CAPAs, audits, NCMRs, and complaint handling systems
Lead implementation of Supplier Change Requests and utilize Production Part Approval Process (PPAP)
Key contributor on NPD (New Product Development) projects, ensuring rigorous performance and APQP deliverables (CTQ, PFMEA, control plan, GRR, FAI, IQ/OQ/PQ, PPA, etc.), in collaboration with Procurement, Manufacturing and R&D
Ensure supplier quality systems adhere to all applicable regulations and standards
Ability to lead and influence cross-functional teams to drive reduction in patient safety risk and greater levels of regulatory compliance
Apply experience and knowledge of MDD (Medical Device Directive), EU-MDR (Medical Device Regulations), ISO 13485 (Quality Management Systems), Pharmaceutical guidelines, FDA, cGMP, and Risk Management (ISO 14971) to instill a culture dedicated to ensuring patient safety and sustained regulatory compliance
Preferred
4-8 years of experience, preferred
Bachelor's degree in related field, or equivalent work experience, preferred
Benefits
Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401k savings plan
Access to wages before pay day with myFlexPay
Flexible spending accounts (FSAs)
Short- and long-term disability coverage
Work-Life resources
Paid parental leave
Healthy lifestyle programs
Company
Cardinal Health
Cardinal Health is a manufacturer and distributor of medical and laboratory products.
10001+ employees
H1B Sponsorship
Cardinal Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (112)
2022 (131)
2021 (144)
2020 (126)
Funding
Current Stage
Public CompanyTotal Funding
$78M2006-08-16Post Ipo Debt· $78M
1983-08-12IPO
Leadership Team
Donald M. Casey Jr.
Chief Executive Officer, Medical Segment
Jason Hollar
CEO
Recent News
2024-12-17
2024-12-17
Company data provided by crunchbase
