Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. 

The Senior Manager, Quality Engineering will directly manage a team of Quality Engineers and oversee the work of a manufacturing area/value stream including product/process transfers, on-going commercial operations & continuous improvement, and new product/process/technology introduction/integration as required.

How you will make an impact:

Responsible for the review, execution/investigation, and approval of NCR & CAPA, Validations, EWO, Risk Management activities, and Quality System changes and updates.  Includes identifying opportunities and leading implementation of process improvements by utilizing Lean methodology and Six Sigma Tools. Will be expected to lead, own, and coach teams through complex/uncharted issues and subsequent solutions (e.g. design or process related CAPA). Manage, mentor and motivate assigned team of Quality Engineers to achieve their potential, while meeting GSC & Quality commitments and project timelines. Develop a robust talent development plan in alignment with functional growth strategies of the department/Site.  Responsible for the overall staff morale and culture for assigned areas and ensuring appropriate resources are allocated for on-going manufacturing operations, Site projects, and product/process transfer activities (e.g. New Product Commercialization and Manufacturing Site Transfer). Manage and/or oversee aspects of project activities with the accountability for successful completion of assigned deliverables related to the business objectives and Plant/Site project plans, schedule, and scope while applying engineering methods (e.g. Six Sigma & Lean methodology) Influence and collaborate with cross-functional team members on strategic program activities and ensuring seamless transition and implementation of new processes and new product commercialization activities (e.g., VIP/value engineering, product engineering, process engineering, advanced engineering, core competencies) Establish/improve operating policies and procedures that affect department, subordinate sections, and work units/manufacturing value streams. Define requirements for validation activities of various manufacturing processes, equipment, and utilities and investigate/address any deviations or failures accordingly. Other incidental duties.

What you’ll need (Required Qualifications):

Bachelor's degree in engineering or scientific field plus at least 8 years of experience within Quality Engineering or Manufacturing Engineering; OR Master’s degree in engineering or scientific field plus at least 7 years of experience within Quality Engineering or Manufacturing Engineering. People leadership/management experience. Experience working within a highly regulated industry.

What else we look for (Preferred Qualifications):

Engineering degree Medical Device or Pharma industry experience Demonstrated experience leading and executing equipment/process validations activities (i.e. IQ/OQ/PQ and Test Method Validations) Experience providing technical guidance on NCRs, CAPAs, test method development, risk management, and root cause analysis Management experience of quality engineers within a medical device manufacturing environment Experience and strong knowledge of quality systems and manufacturing principles Comprehensive understanding of related aspects of quality engineering processes and/or systems Knowledge of Six Sigma methodology and tools such as design of experiments, process capability studies, failure mode and effects analysis, statistical process control, industrial statistical methods and Lean Manufacturing Proven expertise in both Microsoft Office Suite and related systems

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $136,000 to $192,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.