Principal Engineer, Supplier Quality

What Supplier Quality contributes to Cardinal Health

Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

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

• Develop and implement quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

• Provide leadership to technical and administrative personnel with less experience within the Supplier Quality operations and regulatory compliance function.

• Develop, train and guide quality staff, and site personnel to achieve Supplier Quality goals and maintain regulatory compliance. 

• Transferring product designs to manufacturing (Design Transfers) and Mfg. site-to-site transfers.

• Demonstrated knowledge with problem solving (lean six sigma problem solving, CAPA / SCAR investigations).

• Serves as a liaison with Design Engineering/R&D engineering, Medical Safety, Supplier Engineering, and variety of service providing functions on manufacturing and product matters.

• Develop strategies to continuously improve mfg. and product quality and to simplify and optimize processes to increase efficiencies and enhance productivity

• Contributes to or participates in regulatory, customer and corporate audits, and customer technical visits and to provide responses to findings in a timely manner.  

• Participate in Quality Management, Quarterly Business Reviews and Category Operating Unit reporting of KPI metrics to corporate quality functions. 

• Responsible for identifying trends and making decisions that affect products to ensure patient safety.

• Supports the development of department budgets.

• Contributes to the evaluation and selection of suppliers to the assigned Category Operating Unit.

• Monitors supplier performance via quality KPI metrics, reports on performance, and takes appropriate actions to address insufficient performance metrics and / or trends.

Qualifications

• Experience working in large manufacturing medical device plants (+500 employees) preferred.

• A bachelor’s degree in an engineering field required, including one of the following: Biomedical engineering, mechanical engineering, chemical engineering, electromechanical engineering, or industrial engineering, preferred

• 6-10 years of experience in the medical device industry, or highly regulated industry, preferred

• Experience with test method validation, process validation and qualification per FDA requirements and implementing Control Plans, preferred

• Preferred knowledge of AIAG PPAP and/or APQP processes, and with FAI’s.

• Demonstrated knowledge in FDA regulations and ISO 13485 std requirements, Medical Device Regulations (EU MDR) and MDSAP certification, preferred

• Demonstrated knowledge of process for risk management of medical devices and ISO standard 14971, preferred

• ASQ quality engineering certification (ASQ CQE), Certified Quality Auditor (ASQ CQA) preferred

• Demonstrated project management skills and experience, preferred

• Ability to travel up to 30%, Domestic and international (US / Latin America / Asia Pacific).

• Ability to assume responsibility and work independently with little or no supervision

• Working knowledge of business platforms and processes SAP, BPCS and Agile PLM, preferred

• Effective communication and proficient in English (verbal and written), preferred

• Multilingual is preferred (verbal and written), preferred

What is expected of you and others at this level

• Manages department operations and supervises professional employees, front line supervisors and/or business support staff

• Participates in the development of policies and procedures to achieve specific goals

• Ensures employees operate within guidelines

• Decisions have a short term impact on work processes, outcomes and customers

• Interacts with subordinates, peers, customers, and suppliers at various management levels; will interact with senior management

• Interactions normally involve resolution of issues related to operations and/or projects

Anticipated salary range: $80,900 - $115,500

Bonus eligible: No

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• 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

Application window anticipated to close: 5/8/2026 *if interested in opportunity, please submit application as soon as possible.

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

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.

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