St. Jude Medical Quality Engineer II in Plano, Texas

Quality Engineer II


Plano, Texas, USA at

Engineering at

Global Operations-Supply Chain-Quality

160001FYRequisition #

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We are seeking an experienced, high caliber Quality Engineer II to be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within manufacturing area. This includes leading investigation, resolution, and prevention of product and process nonconformances, process validation activities, statistical data analysis, process control and monitoring.

Each employee can make a difference at St. Jude Medical 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 accomplishgoals.

Impact this role will have on St. Jude Medical:

  • 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.

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

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

  • Design and conduct experiments and process validations 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 and resolution of manufacturing related customer complaints.

  • Lead the investigation, resolution and prevention of product and process nonconformances.

  • Participate in teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).

  • Support completion and maintenance of risk analysis files.

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

Your experience(s), education and knowledge will further expand St. Jude Medical’s marketplace success:

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

  • 2-5 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.

  • 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.

Your preferred qualifications and education:

  • Advanced degree preferred.

  • Prior medical device experience preferred.

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

  • ASQ CQE or other certifications preferred.