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Senior Design Quality Engineer

Abbott Laboratories

This is a Contract position in Lenexa, KS posted September 11, 2021.

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 109,000 colleagues serve people in more than 160 countries.

Senior Design Quality Engineer Pomona, or, San Diego, or Remote Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis, and treatment of a range of health conditions.

Abbott’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your health.

We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life.

Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

Our location in Pomona or, San Diego, or Remote currently has an opportunity for a Senior Design Quality Engineer .

This role will be responsible for design quality engineering activities that span the product development process and design transfer to manufacturing.

Included in the role is the responsibility to develop risk management documentation, and use risk management to address product design and process changes, product and process quality issues, and compliance issues.

This person will partner with Research & Development to facilitate the design control process and will partner with operations for process improvement and continuous improvement initiatives.

This person may lead or support the supplier management-related activities for the development of new products including but not limited to: supplier selection and qualification, component qualification, contract development.

WHAT YOU’LL DO Actively partner with operations to perform process audits to identify and implement improvement initiatives Act as quality assurance support for the design and development/on market support of In-Vitro Diagnostics (IVD) medical device products, facilitating the application of design/change controls, risk management, quality plan and implementation of design and development plan.

Work closely with R&D, Manufacturing, Quality Control, and Applications Support management to prevent non-conformities and provide solutions to complex issues.

Support multiple projects, balancing priorities and resources to meet project and management expectations.

Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.

Demonstrates good judgment in selecting methods and techniques for obtaining solutions.

Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations.

Perform root cause analysis of product quality issues.

Apply appropriate tools (e.g.

statistics, fault tree analysis, etc.).

Work with peers to develop corrective actions.

Perform failure mode analysis on new or existing products.

Ensure all reasonable failure modes are identified.

Working with peers, develop mitigations for failure modes, and verify the effectiveness of these mitigations.

Coordinates for both new products/processes and changes to existing products/processes develop verification and validation plans that assess if requirements are met.

Oversee the execution of verification and validation plans in conjunction with validation and process improvement engineers.

Support the QI and CAPA processes by performing investigations and root cause analysis and determining action plans and driving the actions to closure.

Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.

Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.

Carries out duties in compliance with established business policies.

Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.

Perform other duties and projects as assigned.

EDUCATION AND EXPERIENCE YOU’LL BRING Required BS/BA degree in Engineering or field of science such as Chemistry, Microbiology, Biology, Biochemistry) Minimum of 5 years experience in a quality role within a highly regulated industry with 3-5 years of progressively responsible positions Minimum of 3 years hands-on risk management experience in developing and maintaining risk management files such as UMFMEA/DFMEA/PFMEA, Plans, Reports, etc.

Minimum of 3 years of quality engineering experience (design controls/change control, process validation, on-market engineering support, and risk management) in a regulated environment.

Experience reviewing and approving plans and reports for design verification, design validation, and process validations required.

Experience reviewing and approving Device Master Record (DMR) documents required.

Knowledge of Quality System Regulations.

Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor.

Must be detail-orientated, self-motivated, and available for flexible scheduling.

Preferred Direct work experience in IVD or medical device/biotech or regulated manufacturing environment.

Experience acting as a quality lead supporting new product development desired.

Experience with design transfer of products from development to production desired.

Hands-on Design Verification, Design Validation, and Design History File (DHF) experience desired.

Process, QMS, or Supplier auditing experience desired.

Experience with chemistry-related reagent, ELISA, HEIA manufacturing desired.

Lean Six Sigma (Black or Green Belt), Certified Quality Engineer, Certified Quality Auditor desired.

Knowledge of IVDR in EU, FDA QSRs, ISO 13485:2016, ISO 14971:2012 standards.

Goal-oriented learns quickly, works collaboratively with other departments.

Strong writing and verbal communication skills.

Knowledge of computers and software programs including Word, Excel, Access, Visio, MS Project, Minitab, PowerPoint, and Agile.

Experience with root cause analysis, failure mode analysis, verification, and validation.

Statistical tools including basic statistical inference, graphical methods, regression.

Experience with process validations, design verification, and design validation studies.

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 Production areas that are clean, well-lit, and temperature-controlled 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 a 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.

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