Quality Engineer II
Abbott
Summary
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.
Job description
MAIN PURPOSE OF THE 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 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 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.
- Develop, lead and implement Standard Operating Procedure (SOP) and Detailed Work Instruction (DWI) for Business Unit and Process based on existing SOP and DWI
- Manage as primary contact with Distribution Centers regarding discussion of Quality Issue and help coordinate and lead Nonconformance and Corrective Actions for issues
- Support process development and new product introduction for externally manufactured product, component and accessories
Requirements
- Bachelors Degree (± 16 years) in an Engineering or Technical Field or equivalent combination of education and work experience
- Minimum 5 years experience
- 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
Benefits
- Medical coverage
- Retirement savings plan
- Tuition reimbursement
- Student debt program
- Education benefit
Company overview
Abbott Laboratories is a global healthcare leader with a 135-year legacy of innovation, dedicated to helping people live healthier, fuller lives through life-changing technologies and products. Headquartered in Abbott Park, Illinois, the company operates in more than 160 countries with a workforce of approximately 114,000 professionals. Abbott's diversified portfolio spans four core business segments: medical devices, diagnostics, nutrition products, and branded generic pharmaceuticals. The company is particularly renowned for its groundbreaking medical devices including cardiovascular technologies, diabetes management systems like the FreeStyle Libre continuous glucose monitor, neuromodulation devices for chronic pain, and the AVEIR DR dual chamber leadless pacemaker system. In diagnostics, Abbott has been instrumental in developing critical tests, including the first licensed HIV test in 1985 that helped secure blood supply safety. The company's nutrition division produces leading infant formulas like Similac, while its pharmaceutical business provides quality branded generic medicines. Abbott consistently ranks among Fortune's Most Admired Companies and maintains a strong commitment to sustainability and corporate responsibility, making it a trusted partner in advancing global healthcare.