Supplier Quality Manager

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

• Drive the creation of a robust supplier quality lifecycle management strategy, policies and procedures for assigned commodity or product segment beginning with initial supplier selection through retirement

• Establishes processes to technically assess the capabilities of suppliers in a commodity or product segment

• Provide strategic oversight and leadership to technical and administrative personnel within the Supplier Quality and Engineering functions

• Collaborate, develop, and coach supplier quality staff to improve supplier qualification and control procedures to improve supplier oversight, establish effective controls, achieve product quality and service goals, and maintain regulatory compliance

• Serves as a liaison with Strategic Sourcing, Process Engineering, Design Quality, R&D, Medical Affairs, Quality Compliance and Governance, Regulatory, and other technical and service providing functions on supplier quality, manufacturing, and product matters

• Guide direct report team members to greater levels of knowledge and application in Design Control, Corrective and Preventive Action (CAPA, SCARs), Process Validation and Production/Process Controls, Risk Management, Change Management and the company's quality management system

• Identify and lead assigned continuous improvement projects for either suppliers or internal cross-functional teams. Manage applicable internal corrective actions to assure effectiveness and avoid recurrence

• Participating in transferring product designs to manufacturing (Design Transfers) and Mfg. site-to-site transfers and leading the implementation of supplier quality tasks per approved project plans

• Develop strategies to simplify and optimize processes to increase efficiencies and enhance productivity

• Lead supplier management actions for internal and external regulatory compliance audits and provide responses to findings in a timely manner.

• Establish proactive metrics and process to measure product and supplier performance and leads reporting to the various company product quality, operations, and business reviews

• Adhere to all applicable regulations and standards for medical devices and combination products

• Responsible for developing and managing department budget

Qualifications:

• A bachelor's degree in engineering or related field, including biomedical engineering, mechanical engineering, chemical engineering, electromechanical engineering, and industrial engineering or equivalent work experience

• 8+ years' experience in related field and medical industry, preferred

• 2+ years of direct technical leadership experience, preferred

• Experience in working in large medical device company's and manufacturing plants, preferred

• Ability to lead and influence cross-functional teams to drive reduction in patient safety risk and greater levels of regulatory compliance

• Applied experience and knowledge of MDD (Medical Device Directive), EU-MDR (Medical Device Regulations), ISO 13485 (Quality Management Systems), FDA 21 CRR820, cGMP, MDSAP certification, Combination Products, and Risk Management (ISO 14971) to instill a culture dedicated to ensuring patient safety and sustained regulatory compliance

• Proficiency in multi-tasking and working in a high paced environment with an awareness of continued impact on compliance, efficiencies, and operational performance

• ASQ management and/or quality engineering certification (ASQ CMQ/OE, ASQ CQE), preferred

• Demonstrate project management skills and experience

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

• Excellent verbal and written communication skills. Bilingual and proficient in other languages preferred such as Spanish, Mandarin, Chinese

• 20-30% travel is anticipated

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

What is expected of you and others at this level

• Critical and strategic thinking

• Commitment to work within the ethos of the company mission, values, code of conduct and applicable legal standard and regulations

• Managing supplier quality 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

• Gains consensus from and influences various stakeholders

Anticipated salary range : $103,500 - $155,295

Bonus eligible : Yes

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: 1/24/2025 *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.

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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.