Nationwide, US, United States of America
19 hours ago
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 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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