AQR Quality Program Manager – Technical Design Quality

Abbott Laboratories; Plano (TX); On-site; USD 127,000 - 255,000; Full time

Job summary

A leading healthcare company in Plano, Texas is seeking a Manager for Quality Business Support. This role involves supporting quality systems and product submissions within in vitro diagnostics. The ideal candidate will have a bachelor's degree and substantial experience in product design and regulatory compliance. You will develop regulatory interpretations, assess submission risks, and provide feedback to management. The position offers competitive salary and benefits.

Benefits

Free medical coverage

Retirement savings plan

Tuition reimbursement

Career development opportunities

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• 8+ years in product design and development or technical support desired.
• Experience with Class III or II in vitro diagnostics device preferred.

Responsibilities

• Provide corporate-wide support of Abbott’s Quality System.
• Lead submission reviews for US IVD products.
• Analyze and communicate product submission feedback.

Skills

Regulatory compliance

Technical proficiency in diagnostics

Analytical skills

Communication skills

Risk assessment

Education

Bachelor’s degree in technical or science related discipline

Tools

Power BI

Job description

Overview

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.

Primary Job Function

The function of the Manager, Quality Business Support – Technical Design Quality is to provide corporate-wide support of Abbott’s Quality System and product submissions.

The candidate must possess technical proficiency and experience in the area of in vitro diagnostics design development with a working knowledge of the associated Quality System requirements and the regulatory submissions process. The candidate must have sound knowledge of product development and manufacturing processes, as well as experience working in product development and/or technical support teams.

The primary activities and responsibilities expected of this position include providing support for US IVD product submission reviews, and consultation in matters of Quality System and regulatory compliance. This role will serve as a corporate liaison and technical expert primarily to the Abbott in vitro diagnostics businesses, developing and providing a strategic framework through the technical review process implemented to deliver objective feedback and direction for product submissions.

This role is responsible for:

• Developing a standard interpretation of regulatory guidance and feedback for Abbott and facilitating deployment to the divisions.
• Developing, assessing, and communicating key metrics related to product submissions and facilitating implementation of best practices in design and development.
• Providing senior management with assessment of submission risks and potential impacts to both regulatory submissions and sustainability of commercialized products.

The candidate must be able to:

• Organize, perform detailed review, and comprehend large volumes of complex and technical data in a condensed timeframe.
• Assess collective or broader impact of individual challenges identified within reviews.
• Analyze and develop recommendations for actions necessary to support product submissions based on identified risks.
• Effectively communicate, both verbally and in writing, the product submission review feedback to all levels of the organization.
• Lead and facilitate both internal and external meetings to support the review of the product submissions.
• Establish, evaluate and communicate submission review process metrics based on Power BI analysis.
• Develop training, seminars, workshops and/or other appropriate forums to share information and learnings acquired from the technical review process for product submissions.
• Provide ongoing coaching to Abbott businesses throughout the design and development process to promote consistency and standardization.
• Monitor new or changing regulatory requirements. Understand and apply industry lab standards and guidance (e.g. CLSI).

Required Qualifications

• A Bachelor’s degree in technical or science related discipline is required. Advanced degree is preferred, but not required.

Preferred Qualifications

• Minimum 8 years in product design and development and/or technical support desired.
• Class III or II in vitro diagnostics device background. Demonstrated understanding of domestic regulatory requirements and regulating bodies preferred.

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

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 $127,300.00 – $254,700.00. In specific locations, the pay range may vary from the range posted.