Senior Development Quality Engineer
Company: Abbott Laboratories
Location: Saint Paul
Posted on: January 13, 2021
|
|
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 103,000 colleagues
serve people in more than 160 countries.STRUCTURAL HEARTOur
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.We are seeking a Senior
Development Quality Engineer to join our SH team in either our
Saint Paul, MN or Plymouth, MN location. The individual in this
position will assure 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 projects and lead completion of design control
deliverables.Each employee can make a difference at Abbott and has
the power, either individually or as a team, to influence the
success of the company. We are team-oriented, fast-paced and
progressive. We value people with great ideas who partner with
others both internally and externally to take action and accomplish
goals.WHAT YOU'LL DO Primary Duties and Responsibilities:* Lead
on-time completion of Design Control deliverables * Create and
ensure on-time execution of--Quality Plans for internal
development, OEM-based, Clinical Product Development (CPDP), and
design change projects* Accountable for Design Verification and
Validation planning and execution, including active
cross-functional--root-cause analysis investigation and resolution
activities* Lead Risk Management activities, including analyzing
field data to support new product development, and--supporting
Failure Mode Effects Analysis * Support design test and inspection
method development, and lead method validation activities* Ensure
Device History File (DHF) content completion, integrity, and
regulatory & standards compliance; collaboratively identifying,
communicating and resolving gaps* Support manufacturing process
development and qualification for new product commercialization and
product changes* Support internal and external audit responses and
on-time product re-certifications* Support and ensure the
establishment of objective, measurable, discrete, and
verifiable--customer and product requirements* Support and ensure
objective component specification definitions, supplied component
sampling plan development, and vendor qualifications * Support the
development and review of--biocompatibility and sterilization
validations* Supports R&D product builds for bench testing,
animal lab, and first in human activities.* Complete Document
Change Request Reviews in a timely and objective manner*
Participates in Corrective Action/Preventive Action (CAPA) process
including the investigation of failures or deviations, as required.
Develop and lead other team members.Other Duties: * Additional
duties may be identified by functional management based on the
current project/business objectives.* Support all Divisional
initiatives as identified by divisional management and in support
of Quality Management Systems (QMS), Environmental Management
Systems (EMS), and other regulatory requirementsEDUCATION AND
EXPERIENCE YOU'LL BRING Required Qualifications:* Bachelor's degree
within an Engineering field or related science-based discipline*
5-8+ years of related work experience* Previous Quality engineering
experience and demonstrated use of Quality tools/methodologies*
Solid verbal, written, and interpersonal skills with ability to
effectively communicate at multiple levels in the organization*
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 in timely manner.*
Strong organizational and follow-up skills, as well as attention to
detail.* Ability to travel approximately 10%, including
internationally.Preferred Qualifications:* Advanced degree in a
technical field* Medical device experience, specifically with
valves and /or implantable devices* Experience working in a broader
enterprise/cross-division business unit model* Prior experience
working with any or all of the following: * ISO 13485 Medical
Devices - Quality Management System * 21 CFR Part 820 FDA Quality
System Regulations * ISO 14971 Medical Devices - Application of
Risk Management* EUMDR* MDSAP* Good Manufacturing Practices And
Good Documentation PracticesWHAT WE OFFER At Abbott, you can have a
good job that can grow into a great career. We offer: * 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 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, on Facebook at www.facebook.com/Abbott and on
Twitter @AbbottNews and @AbbottGlobal.
Keywords: Abbott Laboratories, St. Paul , Senior Development Quality Engineer, Other , Saint Paul, Minnesota
Click
here to apply!
|
Didn't find what you're looking for? Search again!
Other Other JobsMilitary Intelligence Description: ABOUT Serve at the forefront of national security by analyzing top-secret information and interpreting spy reports. Direct the analysis of top-secret satellite imagery. Be the first to ascertain the implications (more...) Company: Navy Location: Eau Claire Posted on: 01/22/2021 Electronic Processing Spc III Description: normal mso-layout-grid-align:none text-autospace:none Job Summarynormal mso-layout-grid-align:none text-autospace:none TheElectronic Processing Specialist Ill will assist with managing processing (more...) Company: Moneygram Location: Minnetonka Posted on: 01/22/2021 Supplement Your Income - Shop and Deliver Description: FULL-SERVICE SHOPPER Why shop and deliver with Instacart Instacart is the North American leader in grocery delivery. We strive to help make grocery delivery effortless, affordable, and accessible to (more...) Company: Instacart Shoppers Location: Eden Prairie Posted on: 01/22/2021 Experienced Body Tech Description: Job Summary Experienced Auto Body Technician needed to repair vehicles thoroughly, safely, and profitably in a manner consistent with Caliber S.O.P., insurance partner and industry guidelines/standards. (more...) Company: Caliber Collision Location: Eden Prairie Posted on: 01/22/2021 CLIENT SERVICE ASSOCIATE - Non-registered Description: Job DescriptionSUMMARY The Client Services Associate NR assists one or more Financial Advisors FA with the opening and maintenance of client accounts and records performs a wide variety of administrative (more...) Company: Stifel Location: Eau Claire Posted on: 01/22/2021 Customer Solutions Specialist - St. Cloud, MN (FULL TIME) Description: Thomas Edison North 74050 , United States of America, St Cloud, MinnesotaCustomer Solutions Specialist - St. Cloud, MN FULL TIME Capital One prioritizes the health and safety of our associates. In light (more...) Company: Capital One Location: Saint Cloud Posted on: 01/22/2021 Deliver with Uber Eats Description: Job DescriptionDeliver with Uber. Earn on your schedule. Deliver with Uber Eats on your schedule. Deliver for a few hours in the mornings, every night, or just on weekends--it's up to you. Earn Extra (more...) Company: Uber Eats Location: Saint Cloud Posted on: 01/22/2021 Deliver Food with Uber - Flexible Gig Description: Job DescriptionDeliver with Uber. Earn on your schedule. Work on your schedule. Deliver for a few hours in the mornings, every night, or just on weekends--it's up to you. Earn Good Money. You'll Company: Uber Eats Location: Minnetonka Posted on: 01/22/2021 Server - Flexible Hours Description: Overview: Are you looking for an opportunity-to work in your community that allows you to build relationships and make a difference --Our-Beacon Hill-community is seeking Full and Part time Servers / (more...) Company: Presbyterian Homes & Services Location: Minnetonka Posted on: 01/22/2021 Experienced Body Tech Description: Job Summary Experienced Auto Body Technician needed to repair vehicles thoroughly, safely, and profitably in a manner consistent with Caliber S.O.P., insurance partner and industry guidelines/standards. (more...) Company: Caliber Collision Location: Minnetonka Posted on: 01/22/2021 |