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Lead Development Quality Engineer - St Paul, United States - Abbott Laboratories company
Description
Lead Development Quality Engineer page is loadedLead Development Quality Engineer
Apply
locations
United States - Minnesota - St. Paul
time type
Full time
posted on
Posted 2 Days Ago
job requisition id
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 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:
Working at Abbott
At Abbott, you can do work that matters,
grow,
and learn, care for yourself and your family, be your true self, and live
a full
life.
You'll also have access to:
Career development with an international company where you can grow
the career you dream of
.
Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
An excellent retirement savings plan with a high employer contribution
Tuition reimbursement, the
Freedom 2 Save
student debt program, and
FreeU
education benefit - an affordable and convenient path to getting a bachelor's degree.
A company recognized as a great place to work in dozens of countries
around the world
and named one of the most admired companies in the world by Fortune.
A company that
is recognized
as one of the best big companies to work for
as well as
the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
The
position of
Lead Development Quality Engineer is within our Structural Heart team at our St. Paul, MN location.
With our Structural Heart division, the 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.
The individual in this position will ensure that new or modified products conform to requirements and establish compliance with the quality system.
This position is 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.
This position will support new product development projectsas well as support
the sustainability of commercially released products. This position may also support manufacturing processes to meet daily production schedules while enhancing productivity and product quality.
What You'll Work On
Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
Lead on-time completion of project supported Quality deliverables and business initiatives.Support the definition of objective, measurable, discrete, and verifiable customer
requirements, external requirements
, and product requirements.
Lead Risk Management activities from product Concept through Commercialization, including analyzing field data to support new product development and
support Failure Mode Effects Analysis
.
Support Test and Inspection Method development
including
Method Validation activities.
Support Design Verification and Design Validation planning and execution, including cross-functional root-cause analysis investigation and resolution activities.
Support manufacturing process development and qualification for new product commercialization and product changes.
Accountable for Process Validation planning and execution, including active cross-functional root-cause analysis investigation and resolution activities.
Identify and implement effective Process Control and monitoring of CTQ parameters and specifications.
Maintain high standards for Device History File (DHF) content completion, integrity, and regulatory / standards compliance; collaboratively identify, communicate, and resolve gaps.
Support, review, and approve Document Change Order and CAPA recordsin a timely and objective manner
.
Support product builds in the cleanroom for development and commercial activities.
Lead and implement technical team strategy and roadmap.
Assist in
the development of
direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as
appropriate
, and conducting formal written and verbal performance reviews.
Be innovative, resourceful, and work with minimal direction.
Have excellent
prioritization,
organization, problem-solving, communication, and team leadership skills. Work effectively with cross-functional teams.
Build strong collaborative partnerships with cross-functional teams
including
Program Management, Research & Development, and Process Development
to
ensure cross-functional customer needs
are met
without creating barriers to development cost, time, and scope.
Other
Responsibilities:
Support regulatory audits as a Subject Matter Expert for Design Controls and other
aspects of the quality system
.
Support and ensure internal & external audit responses and on-time product re-certifications.
Writes and revises SOPs, controlled forms, and related documents to ensure best practices and
maintain
compliance.
Participate in Corrective Action/Preventive Action (CAPA) process
including
the investigation of
failures or deviations, as required.
Additional duties may
be identified
by functional management
based on current project/business objectives.
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, customers, contractors, and vendors.
Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Required QualificationsBachelor's degree within an Engineering field or a closely related discipline.
6-7+ years of medical device engineering experience and demonstrated use of Quality tools/methodologies.
Familiar with 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, and MDSAP.
Solid verbal, written, and interpersonal skills with the ability to effectively communicate at multiple
levels in the organizations
.
Demonstrated
ability to guide junior team members.
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.
Ability to leverage
and/or
engage others to accomplish projects.
Multitasks prioritizes
and
meets deadlines promptly.
Ability to travel occasionally (
Preferred
Qualifications:
Medical device experience with bioprosthetic heart valve development or manufacturing or
other
implantable device development is strongly preferred.
Previous Development Quality Engineering experience.
ASQ CQE or other certifications.
full
lives:
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
Employer,
committed to employee diversity.
Connect with us at
,
on
Facebook at
, and Twitter @AbbottNews.
The base pay for this position is
$83,000.00 – $166,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
SH Structural Heart
LOCATION:
United States > Minnesota> St
Paul > Woodridge :
177 East County Rd
B
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 5 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
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:
EEO is the Law link - Espanol:
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Abbott
is about the power of health. For more than 135 years,
Abbott
has been helping people reach their potential — because better health allows people and communities to achieve more.
With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life.
Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people ofAbbott
come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people.
We invite you to explore opportunities at
Abbott
, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer,
Abbott
welcomes and encourages diversity in our workforce.
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