What Supplier Quality contributes to Cardinal Health Supplier Quality is responsible for managing external suppliers throughout the product lifecycle, including evaluating and qualifying suppliers, monitoring supplier pe…
Skills: Supplier Quality, Quality Management Systems, ISO 13485, ISO 14971, EU-MDR
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Full-time
bachelor degree
Posted 12d ago
~40 hrs/week
Responsibilities
The Senior Supplier Quality Engineer is responsible for managing external suppliers throughout the product lifecycle, including qualification, performance monitoring, and auditing. They will lead corrective and preventive actions, investigate quality issues, and collaborate with cross-functional teams to ensure regulatory compliance and product quality.
Requirements
Candidates must have a bachelor's degree in Engineering or a similar field and 4-7 years of experience in quality assurance. Proficiency in English and knowledge of medical device regulations such as ISO 13485, EU-MDR, and FDA standards are required.
Full job description
What Supplier Quality contributes to Cardinal Health Supplier Quality is responsible for managing external suppliers throughout the product lifecycle, including evaluating and qualifying suppliers, monitoring supplier performance, auditing supplier's quality management system to applicable regulations and quality standards, providing metrics, and addressing quality and regulatory issues.
Responsibilities
Adhere to Good Manufacturing Principles (GMPs) based Quality Management Systems requirements for medical devices and medicinal products
Lead supplier qualification, evaluation, and monitoring activities to ensure ongoing compliance with quality and regulatory requirements.
Partner with suppliers to improve quality performance, address nonconformances, and implement sustainable corrective and preventive actions.
Identify and lead implementation of preventive and corrective actions via CAPAs, audits, NCRs, and complaint handling systems.
Review and approve supplier quality documentation, change notifications, and quality agreements as applicable.
Lead implementation of Supplier Change Requests.
Plan, conduct, and support supplier audits, assessments, and follow-up activities.
Investigate supplier-related quality issues, identify root causes, and drive timely resolution of complex problems.
Collaborate with Engineering, Operations, Regulatory Affairs, and other cross-functional teams to support product and process quality objectives.
Ensure supplier quality systems adhere to all applicable regulations and standards
Analyze supplier quality trends and metrics to identify risks and improvement opportunities.
Ability to lead and influence cross-functional teams to drive reduction in patient safety risk and greater levels of regulatory compliance
Participate in continuous improvement projects focused on quality system effectiveness and supplier performance.
Support supplier development initiatives that strengthen product quality, compliance, and supply continuity. EU-MDR (Medical Device Regulations), ISO 13485 (Quality Management Systems), FDA, cGMP, and Risk Management (ISO 14971) to instill a culture dedicated to ensuring patient safety and sustained regulatory compliance
Qualifications
4-7 years of experience in quality assurance
2+ years experience as SQE preferred
Bachelor's degree in Engineering or similar field
Advanced English (speaking and reading)
Knowledge of ISO 13485, ISO 14971, EU-MDR, FDA, and cGMP
What is expected of you and others at this level
Knowledge of supplier qualification processes, audits, root cause analysis, CAPA systems, and quality management principles.
Experience working in regulated environments is preferred.
Strong analytical, communication, and stakeholder management skills.
Ability to manage multiple priorities while maintaining attention to detail and quality standards.
Advanced English communication skills.
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
Cardinal Health is a distributor of pharmaceuticals and specialty products; a supplier of home-health and direct-to-patient products and services; an operator of nuclear pharmacies and manufacturing facilities; a provider of performance and data solutions; and a global manufacturer and distributor of medical and laboratory products. Our company’s customer-centric focus drives continuous improvement and leads to innovative solutions that improve people’s lives every day.
Disclaimer: LinkedIn is a third-party site unaffiliated with Cardinal Health. Cardinal Health is not responsible for the privacy or security policies or practices on LinkedIn or on any of the third-party websites that we may link to through LinkedIn. You should carefully review the privacy and security practices of LinkedIn and linked third-party websites. We do not necessarily endorse any information found here nor are we responsible for the accuracy of any information, opinions, claims, or advice found here or shared here by our followers. By posting content, ideas, or pictures, you grant Cardinal Health a non-exclusive, royalty-free, perpetual, and worldwide license to use your content and any images posted by you, including the rights to copy, distribute, transmit, display, reproduce, edit, translate, and reformat, and incorporate into a collective work. Cardinal Health reserves all rights relating to the company's LinkedIn account, including removing postings and prohibiting individuals from participating on the page.
Offices: 7000 Cardinal Place, Dublin, OH 43017, US · 15235 10th Ave, New York, NY 11357, US
How many Management & Leadership jobs are open in Alajuela, Costa Rica right now?
There are currently 68 open management & leadership positions in Alajuela, Costa Rica listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Management & Leadership roles in Alajuela, Costa Rica?
Companies currently hiring include Confluent Medical Technologies, Hologic, Inc., Grupo Dökka, Smith+Nephew, Medtronic, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Management & Leadership jobs in Alajuela, Costa Rica?
Yes — 11 of the 68 open management & leadership positions offer remote or hybrid work (1 remote, 10 hybrid).
How do I apply for Management & Leadership jobs in Alajuela, Costa Rica?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.