Manufacturing Quality Assurance Lead - Folsom

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 Folsom site maintains an ISO 9001:2015 QMS for the manufacturing of Gas Chromatography (GC) Columns and Supplies, Metal Microfluidics (MMF), Sample Preparation, and Bioconsumables. 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.

• Bachelor's or Master's Degree, or equivalent, in Chemistry, Life Sciences, Engineering, or related field.

• Minimum 8 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.