Abbott Senior Quality Engineer in Pleasanton, California

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.

JOB DESCRIPTION:

St. Jude Medical is now Abbott.

We are seeking an experienced, high caliber Sr QS Engineer. 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.

Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.

Impact this role will have on Abbott: - 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

  • Lead, coach, and mentor non-exempt and entry level exempt personnel

  • 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

Your experience(s), education and knowledge will further expand Abbott’s marketplace success: - BS degree in Engineering or Technical Field or equivalent experience; 5+ years’ experience

  • Engineering experience and demonstrated use of Quality tools/methodologies

  • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971

  • Solid communication and interpersonal skills

  • Strong 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

  • Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)

  • 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

  • Ability to travel approximately 10%

  • Ability to maintain regular and predictable attendance

Your preferred qualifications and education: - Advanced degree preferred

  • Demonstrated supervisory experience preferred

  • Prior medical device experience preferred

  • ASQ CQE or other certifications preferred

  • Experience working in a broader enterprise/cross-division business unit model preferred

JOB FAMILY:

Operations Quality

DIVISION:

ASJM Abbott St. Jude Medical

LOCATION:

United States of America > Pleasanton > S4492 : 6035 Stoneridge Dr

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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