Quality Engineer I

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

Job Description

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 I 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 BringBS degree in Engineering in Engineering or Technical Field or equivalent experienceMasters Duty (± 18 years)

Preferred

OR an equivalent combination of education and work experienceEntry level position in which 0-2 years of experience is typical to meet the skills and responsibilities of the position.

Minimum 2 years of Engineering experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971Solid 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 skillsPrior 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.

What We Offer

• 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
• Paid time off401(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
• Learn more about our benefits that add real value to your life to help you live fully : www.abbottbenefits.com
• Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.
• Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $73,900.00 – $116,000.00. In specific locations, the pay range may vary from the range posted.#J-18808-Ljbffr

Skills

• American Society for Quality (ASQ), Business Model, Business Skills, Business Solutions, Cardiac Monitoring, Cardiovascular Disease, Career Development, Certified Quality Engineer (CQE), Communication Skills, Computer Skills, Control Systems, Corporate Policies, Corrective and Preventative Action (CAPA) Systems, Data Analysis, Detail Oriented, Diversity, Documentation Plan, Engineering, Environmental Management Systems, Environmental Monitoring, Establish Priorities, FDA (Food and Drug Administration), FDA Requirements, Facebook, Follow Through, GMP (Good Manufacturing Practices), Healthcare, ISO (International Organization for Standardization), International Health, Interpersonal Skills, Leadership, Lean Manufacturing, Lean Six Sigma, Manufacturing, Manufacturing Systems, Medical Diagnosis, Medical Equipment, Medical Products, Microbiology, Multitasking, Occupational Health, Onboarding, Operations Processes, Organizational Skills, Presentation/Verbal Skills, Problem Solving Skills, Process Control Engineering, Process Development, Process Improvement, Product Development, Product Support, Project/Program Management, Quality Engineering, Quality Management, Regulations, Regulatory Requirements, Reporting Skills, Risk, Statistics, Team Lead/Manager, Technical/Engineering Design, Time Management, Tuition Fees, Twitter, Writing Skills

About the Company

Abbott

At Abbott, we are enthusiastic, energetic and committed to doing great work every day. Our employees are passionate about helping to translate science into lasting contributions to health care and the health of people worldwide.

At the heart of our organization is our "Promise for Life"—a statement that embodies our company's commitment to employees, shareholders, local communities and the people who depend on our company and products to live healthier lives.

Vital to our promise is the speed in which we act, respond and deliver. As Abbott employees, we are ready to meet change and challenges head-on. As a result, we are a company that adapts quickly, and through our passion for innovation we are able to continually create a pipeline of products that help improve the length and quality of life around the world.

We are proud of our rich, more than 120-year history. We continue to be driven to advance leading-edge science and technologies, support diversity, focus on exceptional performance and earn the trust of those we serve.

Company Size:

10,000 employees or more

Industry:

Healthcare Services

Founded:

1910

Website:

http://www.abbott.com/