Abbott Senior Manager, Quality Assurance in Kansas City, Missouri
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 109,000 colleagues serve people in more than 160 countries.
Senior Manager, Quality Assurance – 30975831
Kansas City, MO
Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis, and treatment of a range of health conditions.
Abbott’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.
Our location in Kansas City, MO currently has an opportunity for a Senior Manager, Quality Assurance . In this role, you will help shape the future of the quality journey and create something special within the broader Abbott network.
WHAT YOU’LL DO
Acts as Site Management Representative with overall site responsibility to establish an effective and compliant Quality System that meets changing regulatory requirements and business needs.
Utilizes technical/professional knowledge and skills to establish, interpret and execute company policies.
Supports Operations/Information Technology in continuous improvement initiatives by providing direction on process validation/verification requirements for proposed changes.
Support New Product Initiatives as a Core Team Member supporting design control and design transfer projects.
Developing and/or identifying new work processes that will have broad applicability throughout the company.
Conducting root cause analysis on highly technical problems and solving problems that impact work processes and personnel in multiple units or departments.
Analyzes data makes decisions or provides recommendations to senior staff regarding quality-related crises (e.g. product malfunction, field actions, production hold, customers’ complaints).
Demonstrates effective change leadership by building strategic partnerships across functional areas, business units, and geographies to further departmental and organizational objectives.
Recruits, coaches and develops organizational talent. Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
Manages performance of staff towards department and Company goals, including feedback on performance, appraisals, recommendations for merit increases, or necessary disciplinary actions, communication to employees on performance, etc.
Communicates strategic direction, quality policies/procedures, and effectiveness of the
Quality system to the organization.
Interacts internally and externally with executive level management, outside regulator agencies, customers, vendors, and/or suppliers.
Responsible for exhibiting professional behavior with both internal/external business associates that reflect positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships
Directs and controls the activities and budget of site QA functional operations.
Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification, and validation, manufacturing, and testing activities
Carries out duties in compliance with established business policies
Other duties as assigned, according to the changing needs of the business
EDUCATION AND EXPERIENCE YOU’LL BRING
Bachelor’s Degree in Life Sciences or Engineering or Information Technology / Computer Science
Minimum of 5 years of Quality Assurance work experience in IVD, Medical Devices/Pharma/Biotech organization
Extensive experience working with software/firmware as a medical device in an Agile and/or Waterfall environment.
Knowledge of Quality System Regulations and/or ISO 13485.
Being a subject matter expert and able to lead a team of technical experts in QMS establishment, Design Control, Verification, and Validation, Sofware Development, Software Verification, and Validation.
Experience with cloud-based software.
Strong management skills with proven leadership and team-building skills.
Motivates the team by understanding unique needs and engages in frequent conversations and performance coaching.
Holds others accountable by focusing on the right metrics, tracking results and creating transparent reviews
Excellent organization skills — must be able to manage a large number of simultaneous projects.
Attention to detail — must have precision in work completed, especially as it relates to understanding and documenting complex quality issues.
Attracts, selects, develops, and manages talent for higher levels of performance.
Assesses issues thoroughly and solves complex problems; removes roadblocks for the team
Excellent writing skills — must be able to summarize complex issues in a clear, succinct, and accurate manner. Must be able to write in a manner that effectively conveys complex issues to the reader.
Strong communication, problem-solving and motivational skills.
Demonstrated ability to carry out assignments in a timely, accurate manner and accomplishing tasks as required with little or no supervision.
Ability to interact effectively with all levels of the organization, engage resources and perform multiple tasks in a fast-paced environment.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
A fast-paced work environment where your safety is our priority
Production areas that are clean, well-lit, and temperature-controlled
Training and career development , with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives, and retirement plans
Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
The stability of a company with a record of strong financial performance and a history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: http://www.abbottbenefits.com/pages/candidate.aspx
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com (https://abbott-my.sharepoint.com/personal/katie_english_abbott_com/Documents/Desktop/JDs/www.abbott.com) , on LinkedIn at www.linkedin.com/company/abbott-/ (https://abbott-my.sharepoint.com/personal/katie_english_abbott_com/Documents/Desktop/JDs/www.linkedin.com/company/abbott-/) , on Facebook at http://www.facebook.com/Abbott , and on Twitter @AbbottNews (https://twitter.com/AbbottNews) .
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