Principal Engineer, Supplier Quality

Cardinal Health

2d•Onsite

About The Position

Supplier Quality contributes to Cardinal Health Quality by developing and implementing 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.

Requirements

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

Nice To Haves

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

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.