Design Quality Engineer II (31030146)
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 113,000 colleagues serve people in more than 160 countries.
Design Quality Assurance Engineer II (New Product Development) – Plymouth, MN
Abbott’s Structural Heart division is a high growth business division working on Ventures Trans-Catheter Mitral Valves and novel Structural Heart therapies, allowing people to restore their health and get on with their lives. Our 107,000 colleagues serve people in more than 160 countries.
A Design Quality Assurance Engineer II assures that new or modified products conform to quality standards and establishes compliance with the quality system. You are 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. The Design Quality Assurance Engineer II ensures that medical devices are developed according to good design practices and follow the corresponding requirements set forth by local procedures, regulatory authorities and notified bodies
Execute and support on-time completion of Design Control Deliverables.
Support 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 & execution, including active cross-functional root-cause analysis investigation & resolution activities.
Lead or support Risk Management activities from product Concept through Commercialization.
Support design test and inspection method development, and lead method validation activities.
Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps.
Support manufacturing process development & qualification for new product commercialization and product changes.
Support internal & external audit responses.
Support product re-certifications.
Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements.
Support objective component specification definitions, supplied component sampling plan development, and vendor qualifications.
Support execution of biocompatibility and sterilization qualifications.
Complete Document Change Request Reviews in a timely and objective manner.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
EDUCATION AND EXPERIENCE YOU’LL BRING
Bachelor’s degree in Engineering, Physics, Biology, or Technical field.
2+ years of experience in Quality engineering
Demonstrated use of Quality tools/methodologies
Experience working in the Medical Device or other regulated industry
Working knowledge of the FDA Quality System Regulation
Understanding of current Quality techniques, industry standards (e.g. ISO, IEEE, CMMI), and FDA Quality System Regulations and their impact on internal procedures, quality, safety and efficacy of products
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Experience in risk evaluation techniques, such as PRA (Product Risk Assessment), FMEA & fault tree analysis.
Familiar with reliability analysis and test methods, including HALT and HASS.
Skilled in statistical methods, including ANOVA, statistical process control, sampling plans, gauge R&R, and design of experiments.
Experience working in a broader enterprise/cross-division business unit model preferred.
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.
WHAT 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
Student Loan Repayment Program
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
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 [Register to View] target="_blank">[Register to View] , on Facebook at [Register to View] target="_blank">[Register to View] and on Twitter @AbbottNews and [Register to View]