We are seeking a Quality Assurance Operations Manager to join our Northern California QA Team to support Global Supply Chain operations across multiple plants located in Northern California. You will have 3-5 direct reports and responsibility for a total team of approximately 10 – 15 employees including QA Managers, Quality System Specialists and Quality Engineers. You will also oversee and standardize quality system practices that support manufacturing of diagnostic and life science products across multiple Northern California sites. 
This includes activities such as: 

• Product release and batch record review. 

• Nonconforming product management. 

• Act as Alternate Management Representative. 

• Product & process transfer. 

• Document and Record management. 

• Process, equipment and software validation. 

• Manufacturing and quality system related CAPA investigations. 

• Internal/External/Regulatory audit support. 

• Product transfer support.

How You’ll Make An Impact:

• Collaborate with Quality Systems Manager and Global Design Quality Assurance organization to support initiatives in risk management, QMS harmonization, training, QMS performance monitoring and internal and external audits. 

• Advise site-based teams with appropriate actions in response to identified product performance issues. 

• Participate in the review and approval of technical design documentation such as requirements, risk analyses and validations in support of product development and transfer. 

• Evaluate and authorize product & process changes as requested to ensure product conformity & regulatory requirements are met. 

• Support a wide range of continuous and process improvement initiatives such as: annual quality planning, process flow mapping, employee training and collaborative global quality objectives. 

• Promote an understanding of quality-related requirements and risk-based approaches throughout the organization.

What You Bring:

• Education: Bachelor’s degree or equivalent in a related field. 

• Work Experience: 8+ years relevant experience with supervisory experience, or equivalent combination of education and experience. 

• Experience supervising/ managing a quality assurance program in a regulated environment. 

• Lead ISO auditor certification desirable. 

• Quality Engineer, Quality Manager, Six Sigma Green or Black Belt Certification desirable. 

• Skilled in statistical methods, statistical process control and sampling plans. 

• Communication, public-speaking, decision-making, word processor, spreadsheet, and negotiation skills. 

• Experience as a GMP and/or ISO trainer is highly desirable. 

• Experience approving DHF, validation protocols and risk management files. 

• Experience with risk management regulations and application. 

• Advanced knowledge of the device/drug/biotech manufacturing process.

• Thorough understanding of 21 CFR 820 and ISO standards as they apply to products manufactured.