Location: Singapore / Malaysia
Reporting to: Director, Quality Management
What Supplier Quality brings 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 Engineering 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.
Job Description
Specifically, the Supplier Quality Engineering (SQE) Senior Manager, Asia-Pacific role entails the following:
- To work bi-directionally, representing Global Product Quality within the APAC region for the management of external Finished Goods suppliers located within the region and representing the needs and requirements of the APAC region to the Global Product Quality organization. Global Product Quality is organized into different product categories, which are represented operationally by different Quality leaders (e.g., at Director level). The SQE Senior Manager is responsible integrating the APAC SQE teams in different product categories and to provide a one stop shop for Quality needs locally.
- Responsible for proactive identification and assessment of risks, business continuity threats, resource requirements and funding required to mitigate these and representing these needs to the APAC and Global Product Quality leaders within the QRMA leadership.
- Provide strategic oversight and leadership to the Supplier Quality Engineering teams in the APAC region for the effective management of Finished Goods suppliers throughout the product lifecycle. This will include continuous development and coaching of the Supplier Quality Engineering teams on supplier management procedures to improve supplier oversight, establish effective controls, achieve product quality and service goals, and maintain regulatory compliance.
- Works closely with other functions within and outside of the QRMA (Quality, Regulatory and Medical Affairs) organizations such as Sourcing, Corporate Engineering, R&D, on supplier quality, manufacturing, and product matters related to Finished Goods suppliers located in APAC.
- 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 to simplify and optimize processes to increase efficiencies and enhance productivity with either suppliers or internal cross-functional teams. Manage applicable internal corrective actions to assure effectiveness and avoid recurrence.
- Lead supplier management actions for internal and external regulatory compliance audits and provide responses to findings in a timely manner.
- Participating in transferring product designs to manufacturing (Design Transfers) and Mfg. site-to-site transfers for assigned product category and drive the implementation of supplier quality tasks per approved project plans.
- Establish proactive metrics and processes 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 & Experience
- 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
- 3+ 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 including Procurement, Regulatory Affairs, Technical Services and Research & Development 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 the 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 Mandarin preferred due to supplier base in China
- 20-30% travel is anticipated within APAC region
- Ability to assume responsibility and work independently with little or no supervision
- Organized and resourceful with excellent attention to detail and ability to execute on assigned project plans
- Excellent written and verbal communication skills to drive clear alignment of company and department goals
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 standards and regulations
- Managing Supplier Quality Engineering teams located in the APAC region
- Participates in the development of policies and procedures to achieve specific goals
- Ensure 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
