Quality Engineer II

A healthy heart is essential to good health. That's why we're committed to advancing treatments for people with cardiovascular disease. 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. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. 

We are seeking an experienced, high caliber Quality Engineer II for our Sylmar, CA Operations Quality Engineering team.
 
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.
 
  WHAT YOU’LL DO

- Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
- 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., Six Sigma and Lean Manufacturing)
- Lead the investigation, resolution and prevention of product and process non-conformances
- 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
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
- Performs other related duties and responsibilities, on occasion, as assigned
 
EDUCATION AND EXPERIENCE YOU’LL BRING  

Your experience(s), education and knowledge will further expand Abbott’s marketplace success:

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

-Masters Degree (± 18 years) Preferred

OR an equivalent combination of education and work experience

Minimum 2 years

• 2-5 years Engineering experience and demonstrated use of Quality tools/methodologies.  Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971

• Solid communication and interpersonal skills. 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., Six Sigma and Lean Manufacturing). ASQ CQE or other certifications preferred.

• Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.

The base pay for this position is $81,500.00 – $141,300.00. In specific locations, the pay range may vary from the range posted.

• quality engineering
• process control
• capa systems
• six sigma
• lean manufacturing
• fda regulations
• gmp
• iso 13485
• iso 14971
• statistical analysis
• project management
• communication skills
• problem solving
• team leadership
• interpersonal skills