Senior Quality Engineer

4 weeks ago

Pomona, United States Abbott Full time
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 Title

Senior Quality Engineer

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.
  • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
  • 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 worldwide 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

Responsibilities

The position of Senior Quality Engineer is within our CMI Business Unit. This role will be responsible for quality engineering activities that address one or both of the following:

  • Product/process changes, product/process quality issues, and compliance issues. This includes partnering with operations for process improvement and continuous improvement initiatives, as well as performing process audits of the operations areas.
  • The development of new products, supporting design control activities.

What You’ll Work On

  • Actively partner with operations to perform process audits and identify and implement improvement initiatives as required.
  • Identify and implement effective process control systems to support the development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements.
  • 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 plans, and implementation of design and development plans.
  • Assist in the development and execution of streamlined business systems that effectively identify and resolve quality issues.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Design and conduct experiments for process optimization and/or improvement as required.
  • Work closely with R&D, Manufacturing, Quality Control, and Applications Support management to prevent non-conformities and provide solutions to complex issues as required.
  • Support multiple projects, balancing priorities and resources to meet project and management expectations.
  • Appropriately document experiment plans and results, including protocol and report writing/reviews.
  • Lead in the completion and maintenance of risk analysis.
  • Lead process control and monitoring of CTQ parameters and specifications as required.
  • Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
  • Lead the investigation, resolution, and prevention of product and process non-conformances as required.
  • Support all BU/Division initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Work with design engineering in the completion of product verification and validation as required.
  • Work on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
  • Demonstrate good judgment in selecting methods and techniques for obtaining solutions.
  • Lead, coach, and mentor entry-level exempt personnel.
  • 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. Work with peers to develop mitigations for failure modes and verify the effectiveness of these mitigations.
  • Coordinate the development of verification and validation plans for both new products/processes and changes to existing products/processes to assess if requirements are met. Oversee the execution of verification and validation plans in conjunction with the Quality Validation Engineer.
  • Exhibit professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
  • Understand and be aware of the quality consequences that may occur from the improper performance of specific job duties. Be aware of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing, and testing activities.
  • Carry out duties in compliance with established business policies.
  • Demonstrate commitment to the development, implementation, and effectiveness of the Quality Management System per ISO, FDA, and other regulatory agencies.
  • Perform other duties and projects as assigned.

Required Qualification

  • BS/BA degree in a field of science such as Chemistry, Microbiology, Biology, Biochemistry, or Engineering.
  • Minimum of 5 years of experience in a quality role within the Biotechnology industry, with 3-5 years in progressively responsible positions.
  • Minimum of 3 years of hands-on risk management experience in maintaining risk management files.
  • Minimum of 3 years of manufacturing/quality engineering experience (design controls/change control, process validation, on-market engineering support, and/or design transfer) in a regulated environment.
  • Experience reviewing and approving process validations, equipment qualifications, design verifications, and/or design validations required.
  • Experience reviewing and approving Device Master Record (DMR) documents required.

Preferred Qualifications

  • Direct work experience in IVD, medical device/biotech, or a regulated manufacturing environment.
  • Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
  • Experience acting as Quality Lead supporting new product development desired.
  • Experience with transferring a product from development to production desired.
  • Hands-on experience with Design Verification, Design Validation, and Design History File (DHF) desired.
  • Process, QMS, or Supplier auditing experience desired.
  • Advanced computer skills, including statistical/data analysis and report writing skills.
  • Experience with reagent, ELISA, and HEIA manufacturing desired.
  • Lean Six Sigma (Black or Green Belt), Certified Quality Engineer, or Certified Quality Auditor desired.
  • Demonstrated supervisory experience preferred.
  • Knowledge of IVDR, FDA QSRs, ISO 13485, and ISO 14971 standards.
  • Goal-oriented, quick learner, and able to work collaboratively with other departments.
  • Strong writing and verbal communication skills.
  • Proficient in software programs including Word, Excel, Access, Visio, MS Project, Minitab, PowerPoint, and Agile.
  • Experience with root cause analysis, failure mode analysis, verification, and validation.
  • Proficient in statistical tools including basic statistical inference, graphical methods, and regression.
  • Experience with process validations, design verification, and design validation studies.
  • Knowledge of Quality System Regulations.
  • Able to work on multiple tasks as a team member and/or as an individual contributor.
  • Must be detail-oriented, self-motivated, and available for flexible scheduling.

Competencies

  • Analytical Skills (e.g. statistical, risk analysis, engineering analysis)
  • Team player
  • Interpersonal Skills
  • Drives for results
  • High level of attention to detail
  • Collaboration

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

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.

The base pay for this position is $83,600.00 – $167,200.00. In specific locations, the pay range may vary from the range posted.

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