Abbott Operational Excellence Analyst II in Plymouth, Minnesota
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 107,000 colleagues serve people in more than 160 countries
Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of STRUCTURAL HEART disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.
For years, Abbott’s MEDICAL DEVICES businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ﬁnger sticks.
WHAT YOU’LL DO
Communicates verbally and in writing both internally and externally regarding information needed specific to product complaint management activities (e.g. supporting departments, international offices, other complaint handling organizations within Abbott, IT, etc.)
Conducts process gap analysis based on regulatory requirements and system functionality to support process improvement initiatives
Supports complaint database upgrades and conversions by providing input and performing system testing
Ensures accurate department procedures and work instructions are maintained; Support inspections by regulatory agencies (e.g. FDA, TUV) as requested.
Implements document updates including appropriate justification via the change control system
The Product Surveillance Operational Excellence Analyst must be able to:Collaborate independently with other team members and departments; Understand the complaint handling process in its entirety and assess process improvement opportunities; Utilize experience and knowledge of how Complaint Handling, Design Quality and Risk Management components of the Quality System function holistically to meet regulatory requirements to drive improvement; Be able to query data from multiple IT Systems and assemble data into a usable format; Employ strong investigative skills and translate learnings into process improvements; Demonstrate strong skills for math, data analysis with strong skills manipulating spreadsheets.
EDUCATION AND EXPERIENCE YOU’LL BRING
Four-year degree, preferably in the healthcare or science fields; engineering is a plus. Degreed applicants without medical, scientific, or complaint handling experience may be considered if they possess the strengths suitable for this position.
2-3 years experience in Product Surveillance for medical products or equivalent experience working in within a Quality System for medical devices
Knowledge of global regulations for medical device reporting and medical terminology is a plus.
Strong written and oral communication skills are required.
Candidate must be able to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously.
Additionally, the Product Surveillance Operational Excellence Analyst II must demonstrate leadership and be able to lead projects and CAPA investigations.
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 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: * www.abbottbenefits.com at 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 at http://www.abbott.com/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal
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 email@example.com