Senior Quality Engineer

 •  Abbott Liberty, SC

5 - 7 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 11/27/17
Liberty, SC
5 - 7 years experience
Biotech/Pharma
Salary depends on experience
Posted on 11/27/17

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than125years, we've brought new products andtechnologies 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 than150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.

     

JOB DESCRIPTION:


We are seeking an experienced, high caliber Senior Quality Engineer to be responsible for developing and maintaining quality engineering methodologies and providing quality engineeringsupport 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 withothers 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 nonconformances
  • 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; advanced degreepreferred
  • 5+ years’ experience
  • Engineeringexperience and demonstrated use of Quality tools/methodologies
  • Detailed knowledge of FDA, GMP, ISO13485, and ISO14971
  • Solid communication and interpersonal skills
  • Advanced computer skills, including statistical/data analysis and report writing skills
  • 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 preferredqualifications and education:

  • 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
  • Prior medical device experiencepreferred
  • Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
  • ASQ CQE or other certifications preferred

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