Abbott Senior Quality Engineer - Distribution in Roseville, Minnesota
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.
We are seeking a high achieving Senior Quality Engineer to be responsible for developing and maintaining quality engineering methodologies and support within our manufacturing and distribution environments.
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 collaborative, dynamic and progressive. We value people with new ideas who partner with others both internally and externally to take action and accomplish goals.
Impact this role will have on Abbott:
You will help identify and implement effective process control systems to support the development, qualification, and ongoing manufacturing of products
You will lead the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
Lead, coach, and mentor your non-exempt and entry level exempt team members.
Participate 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
You will design and conduct experiments for process optimization and/or improvement
Appropriately develop and document Quality plans and reports
Lead process control and monitoring of CTQ parameters and specifications
Lead and implement various process improvement methodologies
Lead the investigation, resolution and prevention of 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
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS).
Follows U.S. Food and Drug Administration (FDA) regulations, 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 degree preferred
5+ years’ experience
Engineering experience and shown use of Quality tools/methodologies
Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
Shown communication and interpersonal skills
Advanced computer skills, including statistical/data analysis and report writing skills
Able to excel in a highly matrixed and geographically diverse business environment
Ability to work within a team and as an individual contributor in a dynamic, 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:
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 experience preferred
Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
ASQ CQE or other certifications preferred
SAP system experience
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 firstname.lastname@example.org