Quality Engineer - Structural Heart

Job description

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 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

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:

We are seeking an experienced, high caliber Sr Quality Engineer to be 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.

This role is an individual contributor position, requiring the candidate to have comprehensive knowledge in the specific area. Seeking a candidate who:

• Has ability to execute highly complex or specialized projects.
• Adapts precedent and may make significant departures from traditional approaches to develop solutions.
• Will be responsible for designing and maintaining programs for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met.
• Under general direction, has duties of instructing, directing, and checking the work of other quality assurance professionals.
• Will be responsible for application of quality principles and complex analysis of quality records, reports to form recommendations for improvements.
• Will conduct inspection, verification and validation of components or materials used in development processes
• Able to identify and address recurring problems either with the quality of the product or the reliability of testing procedures.
• Will document quality issues and performance measures for management review.
• May liaise with external vendors.

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

Your experience(s), education and knowledge will further expand Abbott’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
• 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
• ASQ CQE or other certifications preferred
• Prior medical device experience preferred
• Experience working in a broader enterprise/cross-division business unit model preferred

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