Manufacturing Quality Assurance (QA) Lead - Shanghai

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic, and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Agilent enables customers to gain the answers and insights they seek – so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.

Our Global Operations Quality Assurance organization leads a customer-focused quality culture providing expertise, training, and consulting of quality processes for internal customers. Manufacturing Quality Assurance is responsible for the implementation, execution, and oversight of the local Quality Management System (QMS) in collaboration with our cross-functional partners.

The Shanghai site maintains an ISO 9001:2015 QMS for the manufacturing of Columns and Consumables for Gas Chromatography (GC), Liquid Chromatography (LC), and other Applied Markets and Life Science instrumentation. Responsibilities of the Manufacturing Quality Assurance Lead include:

• Own the local ISO 9001:2015 QMS processes in alignment with Agilent-, group-, and division-level QMS including Nonconformance Management, Corrective and Preventative Actions (CAPA), Change Control, Training, Risk Management, and Process and Equipment Validation.
• Ensure an effective Training Management process at the site with clarity for roles and responsibilities, employee qualifications, and training requirements.
• Provide Quality Assurance support to Manufacturing for production issues to ensure alignment and conformity to the appropriate QMS processes.
• Collaborate with Manufacturing and Supply Chain for product shipment holds and support Product Investigations and Field Actions.
• Continuously monitor product quality and process controls through face-to-face engagement with Manufacturing personnel to identify opportunities and support continuous improvement.
• Oversee incoming, in-process, and Quality Control (QC) inspection and approve inspection plans.
• Monitor and report Quality and Customer Experience data against established metrics. Ensure ownership and accountability of actions to address off-target or negatively trending performance.
• Lead audit management activities for the site including scope definition, audit preparation, host audits, support actions to address findings, and communicate to stakeholders.
• Represent Quality Assurance during customer interactions for QMS Questionnaires, Quality Agreements, Change Notifications.
• Support Design Transfer activities for new and revised products managed under the Product Lifecycle (PLC) process.
• Collaborate with Supplier Quality to ensure supplier management processes are effective and aligned with the site needs.

This position is a full-time on-site role.

Agilent is an equal opportunity employer.

• University degree, or equivalent, in Chemistry, Life Sciences, Engineering, or related field.
• Minimum 4 years’ experience with Quality Assurance, ISO Compliance, and/or Quality Management Systems.
• Experience with ISO 9001:2015, or similar.
• Experience preparing for and hosting audits.
• Experience with multiple QMS processes: Change Control, Training Management, Nonconformance Management, Corrective and Preventative Actions, Design Control, Risk Management, and/or Validation.
• Effective communication skills with ability to work independently and collaborate with cross-functional and global teams.