JOB DESCRIPTION:2nd shift Quality Engineer IIThe Opportunity This position works out of our
Minnetonka, MN location in the Electrophysiology division. In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
As the
2nd shift Quality Engineer II, you'll support sustainability of commercially released product ensuring manufacturing processes meet daily production schedules while enhancing productivity and product quality. You will assure all products conform to the establish compliance requirements within Abbott's Quality Management System. You are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
Second shift schedule: Monday - Thursday, 2:30 PM - 12:30 AM CST with occasional overtime on Fridays
What You'll Work On- Identify and implement effective process control systems to support the 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.
- Work with cross functional teams to 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.
- 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
- Ability to work 2nd shift hours
Required Qualifications- Bachelor's Degree in engineering or Technical Field or an equivalent combination of education and work experience
- 2-5 years Engineering experience and demonstrated use of quality tools/methodologies. Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
- 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
- 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
Preferred Qualifications- Prior medical device experience preferred.
- CAPA owner or a key cross-functional team member leading a CAPA.
Apply NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
The base pay for this position is $61,300.00 - $122,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations Quality
DIVISION:EP Electrophysiology
LOCATION:United States > Minnesota > Minnetonka : 14901 DeVeau Place
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Not specified
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Work in a clean room environment
