9 Development Quality Engineer II Jobs in Plymouth, MN
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Development Quality Engineer II
$86k-103k (estimate)
Full Time | Transportation
1 Week Ago
Abbott is Hiring a Development Quality Engineer II Near Plymouth, MN
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.
Working at AbbottAt Abbott, You Can Do Work That Matters, Grow, And Learn, Care For Yourself And Family, Be Your True Self And Live a Full Life. You’ll Also Have Access To
As the Development Quality Engineer II, you’ll have the chance to 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, such as design verification, design validation and risk management.
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 act and accomplish goals.
What You’ll Work On
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. 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.
The base pay for this position is $57,300.00 – $114,700.00. In specific locations, the pay range may vary from the range posted.
Working at AbbottAt Abbott, You Can Do Work That Matters, Grow, And Learn, Care For Yourself And 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 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 a best place to work for diversity, working mothers, female executives, and scientists.
As the Development Quality Engineer II, you’ll have the chance to 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, such as design verification, design validation and risk management.
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 act and accomplish goals.
What You’ll Work On
- Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Design Quality function as a Core Team Member)
- 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 or support Risk Management activities, including analyzing field data to support new product development, supporting Failure Mode Effects Analysis, generation of risk management plans/reports, and completion of hazard analysis
- Support design test and inspection method development, and lead test 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
- 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.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
- 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
- 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 requirements
- Bachelor’s degree within an Engineering field or related science-based discipline
- 2-5 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 up to 10%.
- This is not a work from home position
- Advanced degree in a technical field
- Medical device experience, specifically with heart 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 Practices
- Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. 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.
The base pay for this position is $57,300.00 – $114,700.00. In specific locations, the pay range may vary from the range posted.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Transportation
SALARY
$86k-103k (estimate)
POST DATE
06/10/2024
EXPIRATION DATE
07/06/2024
WEBSITE
abbott.co.nz
HEADQUARTERS
TORONTO, ONTARIO
SIZE
25 - 50
FOUNDED
1981
TYPE
Private
CEO
JOHN J. HUMPHREYS
REVENUE
<$5M
INDUSTRY
Transportation
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About Abbott
Abbott is a financial brokerage firm that offers business, personal and health insurance, and home loan services for individuals.
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The job skills required for Development Quality Engineer II include Analysis, Problem Solving, ISO, Collaboration, Initiative, Product Development, etc. Having related job skills and expertise will give you an advantage when applying to be a Development Quality Engineer II. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Development Quality Engineer II. Select any job title you are interested in and start to search job requirements.
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The following is the career advancement route for Development Quality Engineer II positions, which can be used as a reference in future career path planning. As a Development Quality Engineer II, it can be promoted into senior positions as a Quality Assurance Engineer III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Development Quality Engineer II. You can explore the career advancement for a Development Quality Engineer II below and select your interested title to get hiring information.
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