Sr. Clinical Quality Associate
Job Description
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 115,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
About Abbott
For years, Abbott’s medical device 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
fingersticks
.
Abbott Vascular provides innovative, minimally invasive and cost-effective products for
treatment
of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure
devices
and peripheral stents
Our location in
Maple Grove, MN
, currently has an opportunity for a
Senior Clinical Quality Associate
.
This position could also be
based out of
ourPlano, TX
site.
THIS IS AN IN-HOUSE POSITION - NO REMOTE
NO RELOCATION ASSISTANCE IS AVAILABLE FOR THIS POSITION.
WHAT YOU'LL DO:
Primary Job Function:
Responsible for supporting Global Clinical Affairs personnel globally in ensuring compliance with medical device and GCP regulations and standards, as well as company policies and procedures and other applicable requirements.
Core Job Responsibilities:
Responsible for compliance with applicable regulations and standards, as well as Corporate and Divisional Policies and procedures.
Study Support
· Review study documents for compliance
to
applicable regulations, standards, and internal procedures
· Act as a resource to clinical study teams
regarding
compliance
to
regulations, standards, and Abbott procedures
· Support compliant execution of clinical research projects
· Preferably has prior experience with GCP regulations and standards, including 21 CFR Parts 50, 54, 56, 812 and ISO 14155
CAPA
· Generate CAPA documentation, including investigations, resolution plans, and implementation reports
· Ensure work
complies with
regulatory and compliance standards
· Work cross-functionally to develop pragmatic and compliant solutions for CAPA activities
· Drives continuous process improvement
· Strong written communication skills
Internal/External Audits
· Key player in the preparation and overall support for internal and external audits, including responding to audit findings such as through the CAPA process
· May perform internal compliance assessments and/or audits
· Support project teams in preparation for regulatory authority inspection or audit, or corporate or divisional regulatory compliance audit
May support other clinical quality tasks as requested and as
need arises
.
Position Accountability / Scope:
Job/Technical Knowledge:
· Strong understanding of Good Clinical Practice (GCP) including U.S. regulations and international standards, Quality Assurance/Control, as well as of relevant regulations and procedures
· Cooperation/Teamwork: team player with autonomy capable of working independently under minimal supervision
· Planning and organizational
skills:
organizes self in an efficient manner
· Problem
solving:
gathers information before making decisions; weighs alternatives against
objectives
and arrives at reasonable decisions
· Adaptability:
remains
open-minded; performs a wide variety of tasks and changes focus quickly as demands change
· Initiative /
Innovation:
explores alternative successful ways of working and tools; able to challenge conventional practices; creates novel solutions to problems
EDUCATION AND EXPERIENCE YOU’LL BRING:
REQUIRED QUALIFICATIONS
Bachelors
Degree(± 16 years), In related field OR an equivalent combination of education and work experience
Minimum 4 years, Related work experience with a solid understanding of
specified
functional area.
Broad knowledge and application of business concepts,
procedures
and practices.
Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
Learns
to use professional concepts and company policies and procedures to solve routine problems.
Works on problems
of
limited scope.
Independent decision making
required
.
PREFERRED QUALIFICATIONS
Prefer a
t least 5 years of medical devices, clinical research experience, or related industry. Prefer at least 3 years of related work experience in Quality role in medical device area and/or clinical trial environment.
Prefer
GCP audit experience.
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
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:
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
, on Facebook at
and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
$78,000.00 – $156,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Clinical Affairs / Statistics
DIVISION:
MD Medical Devices
LOCATION:
United States > Maple Grove : 6820 Wedgwood Road N.
ADDITIONAL LOCATIONS:
United States > Texas > Plano : 6600 Pinecrest
WORK SHIFT:
Standard
TRAVEL:
Yes, 5 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
