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.
We are seeking an experienced, high caliber Design Quality Engineer II to be responsible for 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.
Impact this role will have on Abbott:
- Responsible for ensuring that Design Controls are properly included in the Development process.
- Responsible for ensuring that Design for Reliability, Risk Management and Quality are central to our Development process.
- Responsible for leading risk management and design verification for new product development .
- 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
- 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)
- 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.
- 2+ years of relevant medical device industry experience or experience in a regulated environment.
- Solid written and oral 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
- Multitasks, prioritizes and meets deadlines in timely manner
- Strong organizational and follow-up skills, as well as attention to detail
- Ability to travel approximately 5%
Your preferred qualifications:
- Advanced Engineering/Technical graduate degree.
- 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
- 5+ years’ experience
- Prior medical device design quality/product development experience preferred
- New product development engineering experience and demonstrated use of Quality tools/methodologies, including design requirements, risk management and design verification
- Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
- Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)