Sr Quality Engineer - Exempt

The candidate will be part of the Diabetes Post-Market Quality Engineering team. This role primarily involves supporting quality deliverables for product launches and the global expansion of existing products. The individual will also engage with the extended quality core team for next-generation products to ensure post-market quality is integrated into the development process. The ideal candidate should effectively represent all post-market quality functions, collaborate well with others, and manage timelines and project deliverables efficiently.
Key Requirements

• Post-Market Quality Engineering experience
• Preference for product quality support over manufacturing, testing, or supplier quality experience
• Experience in Risk Management / Failure Assessment

Educational and Experience Requirements

• Education: Bachelor's degree in engineering, science, or technology discipline
• Experience: 4-10 years preferred

Work Schedule and Location

• Work Hours: 40 hours per week
• Location: Northridge
• On-site Requirement: Hybrid (minimum 3 days/week on-site)

Responsibilities
Responsibilities may include the following and other duties may be assigned:

• Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished products.
• Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
• Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in areas such as design, incoming material, production control, product evaluation and reliability, inventory control, and/or research and development as they apply to product or process quality.

Career Stream and Differentiating Factors
Specialist Career Stream: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
Autonomy: Seasoned individual contributor working independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower-level specialists; may manage projects/processes.
Organizational Impact: May be responsible for entire projects or processes within the job area. Contributes to the completion of workgroup objectives through building relationships and consensus to reach agreements on assignments.
Innovation and Complexity: Problems and issues faced are difficult and may require understanding of multiple issues, job areas, or specialties. Makes improvements to processes, systems, or products to enhance job area performance. Analysis provided is in-depth and often includes recommendations on process improvements.
Communication and Influence: Communicates with senior internal and external customers and vendors. Exchanges information of facts, statuses, ideas, and issues to achieve objectives and influence decision-making.
Leadership and Talent Management: May provide guidance, coaching, and training to other employees within the job area. May manage projects, requiring delegation of work and review of others' work product.
Required Knowledge and Experience
Requires advanced knowledge of the job area, combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience.