AQR Quality Program Manager – Technical Design Quality at Abbott

North Chicago, Illinois, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Diagnostics, Medical DevicesIndustries

Requirements

Technical proficiency and experience in in vitro diagnostics (IVD) design development
Working knowledge of associated Quality System requirements and regulatory submissions process
Sound knowledge of product development and manufacturing processes
Experience working in product development and/or technical support teams
Ability to organize, perform detailed review, and comprehend large volumes of complex and technical data in a condensed timeframe
Ability to assess collective or broader impact of individual challenges identified within reviews
Ability to analyze and develop recommendations for actions necessary to support product submissions based on identified risks
Ability to effectively communicate, both verbally and in writing, product submission review feedback to all levels of the organization
Ability to lead and facilitate both internal and external meetings to support product submission reviews
Ability to establish, evaluate, and communicate submission review process metrics based on Power BI analysis
Ability to develop training, seminars, workshops, or other forums to share information and learnings from the technical review process
Ability to provide ongoing coaching to Abbott businesses throughout the design and development process to promote consistency and standardization
Ability to monitor new or changing regulatory requirements and understand/apply industry standards

Responsibilities

Provide corporate-wide support of Abbott’s Quality System and product submissions
Serve as a corporate liaison and technical expert primarily to Abbott in vitro diagnostics businesses
Develop and provide a strategic framework through the technical review process for objective feedback and direction on product submissions
Develop a standard interpretation of regulatory guidance and feedback for Abbott and facilitate deployment to the divisions
Develop, assess, and communicate key metrics related to product submissions and facilitate implementation of best practices in design and development
Provide senior management with assessment of submission risks and potential impacts to regulatory submissions and sustainability of commercialized products
Provide support for US IVD product submission reviews and consultation in matters of Quality System and regulatory compliance

Skills

Key technologies and capabilities for this role

In Vitro DiagnosticsDesign DevelopmentQuality SystemRegulatory SubmissionsProduct DevelopmentManufacturing ProcessesTechnical Support

Questions & Answers

Common questions about this position

What benefits does Abbott offer?

Abbott provides career development opportunities, free medical coverage through 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.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What skills and experience are required for this role?

The role requires technical proficiency and experience in in vitro diagnostics design development, working knowledge of Quality System requirements and regulatory submissions, sound knowledge of product development and manufacturing processes, and experience in product development or technical support teams.

What is the company culture like at Abbott?

Abbott emphasizes doing work that matters, personal growth and learning, caring for yourself and family, being your true self, and living a full life, and is recognized as a great place to work, one of the most admired companies, and best for diversity, working mothers, female executives, and scientists.

What makes a strong candidate for this position?

A strong candidate will have technical proficiency in in vitro diagnostics design development, knowledge of Quality System requirements and regulatory submissions, experience in product development or technical support, and the ability to provide strategic framework, develop metrics, and assess submission risks for senior management.

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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