Sr. Design QA Specialist

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 115,000 colleagues serve people in more than 160 countries.

Sr. Design QA Specialist

Des Plaines, IL

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At 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.

The Opportunity

This position works out of our Des Plaines, IL Headquarters of Abbott Molecular, We are a division of Abbott Laboratories, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics

The Sr. Design Quality Assurance Specialist position will be responsible for supporting new assay product design and on-market product development/change teams as the primary Design QA representative. We are looking for a highly motivated professional with Assay Product Development/On-Market Assay Change Control and Lifecycle Management experience and a successful track record in the global regulated medical device environment, as well as people leadership experience or potential.

QUALIFICATIONS

• 5+ years experience related to Assay Development/ On-Market Assay change control and Lifecycle Management.
• Experience with assay verification and validation testing review, including review of clinical studies.  
• Strong knowledge & experience with assay product related regulations in the US, EU and emerging markets.  
• Strong quality focus to ensure adherence to the quality system and regulations.
• Strong understanding of Design Controls and Risk Management regulations and documentation requirements.
• Ability to analyze and evaluate technical data/quality information to ensure appropriate evaluation of product safety and efficacy, implementation of adequate risk controls and elevation of risk-based issues.
• Experience in CAPA investigations, resolution plans and implementation of corrections, corrective and preventive actions.
• Excellent skills in the areas of communication, teamwork, problem solving, detailed verification and validation study reviews, organization, strategic thinking, time management, multi-tasking and technical writing.
• Proven team leadership skills and ability to lead by influence.

The candidate for this position will support:

• Assay Product development/ On-Market Assay Change control and lifecycle management
• Development, approval, and change control of Design History documentation (e.g Design Input and Design Outputs, Design V&V protocols and records, Change Impact Assessment Plans, Risk Management Plans/Reports, DFMEAs, FMEAs)
• Related quality system updates in alignment with regulatory requirements.
• Assay related cause investigations and corrective actions.
• Planned updates to design control and other quality system procedures and records.
• Risk management evaluation and updates related to assay product.
• May have 1-3 direct reports.

Apply Now

* 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.

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 and @AbbottGlobal.

The base pay for this position is $80,700.00 – $161,300.00. In specific locations, the pay range may vary from the range posted.

• capa
• product safety
• lifecycle management
• team leadership
• product design
• risk management
• product development
• risk management plans
• risk management regulations
• people leadership
• medical science
• technical data
• preventive actions
• assay
• strategic thinking
• assay development
• risk management evaluation
• technical writing
• quality focus
• regulatory requirements
• impact assessment
• capa investigations
• quality assurance