Abbott Sr Quality Engineer in Abbott Park, Illinois

At Abbott, we're committed to helping people live their 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, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

MAIN PURPOSE OF ROLE

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.

MAIN RESPONSIBILITIES

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, 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 methodoligies (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 Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

Performs other related duties and responsibilities, on occasion, as assigned.

QUALIFICATIONS

Education

Bachelors Degree (± 16 years)

Engineering or Technical Field or an equivalent combination of education and work experience

Experience/Background

Minimum 5 years

Demonstrated supervisory experience preferred. 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. Prior medical device experience preferred. Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).

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. Ability to maintain regular and predictable attendance.

ASQ CQE or other certifications preferred

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com