Quality Engineering- Contractor

As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people's health so they can get back to living their best lives faster. Quality Engineer II in Sylmar, CA . This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.

Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.

Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues.

Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Design and conduct experiments for process optimization and/or improvement.

Appropriately document experiment plans and results, including protocol writing and reports.

Lead process control and monitoring of CTQ parameters and specifications.

Lead and implement various product and process improvement methodologies (e.g., Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).

Lead in the completion and maintenance of risk analysis.

Work with design engineering in the completion of product verification and validation.

Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities.

Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

BS degree in Engineering in Engineering or Technical Field or equivalent experience.

OR an equivalent combination of education and work experience.

2-5 years Engineering experience and demonstrated use of Quality tools/methodologies. Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner. Advanced computer skills, including statistical/data analysis and report writing skills.

Prior medical device experience preferred. Experience implementing various product and process improvement methodologies (e.g., Experience working in a broader enterprise/cross-division business unit model preferred. Ability to leverage and/or engage others to accomplish projects. Training and career development , with onboarding programs for new employees and tuition assistance.

Financial security through competitive compensation, incentives and retirement plans.

Health care and well-being programs including medical, dental, vision, wellness and occupational health programs.

401(k) retirement savings with a generous company match.

The stability of a company with a record of strong financial performance and history of being actively involved in local communities.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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