Senior Professional Quality - REMOTE / Boston, MA , New Hampshire

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Posted 11 days ago United States Salary undisclosed
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Job Description

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.

This position can be located in - Boston MA / New Hampshire/ Remote

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.

At Abbott Molecular, we realize the potential of personalized care as the laboratory's most trusted and preferred source for molecular diagnostic solutions. We are a division of Abbott Laboratories, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics.

Abbott Molecular - Our Des Plaines, IL site has an opportunity for a Senior Professional Quality with design control/change control and manufacturing experience.

Position Summary:

Defines project goals and milestones.

Responsible for timely project completion.

Provides solutions to a wide range of difficult problems.

Ensures that solutions are compliant, innovative, thorough, practical and consistent with organizational objectives.

May lead projects with cross-functional or broader scope.

Interacts effectively with employees, manager, and cross-functional peers

WHAT YOU WILL DO:

Directly influences project direction and scope.

Scope includes one or more QA functions, with general knowledge of other related disciplines.

Provides guidance and trains other Professionals and Technicians.

May provide oversight to one or more QA professionals and/or contractors.

Ensures compliant documentation.

Quality System Compliance :

  • Demonstrates good, general understanding of the standards and regulatory bodies that regulate our industry.
  • Ensures compliance to site level policies and procedures and demonstrates a solid understanding of Division and Corporate policies and procedures by promptly addressing noncompliance issues within Division and Corporation as appropriate.
  • Ensures adherence and maintains the effectiveness of the Quality System, including the Subsystems and Key processes that govern the area by promptly addressing non-compliance issues.

**Design Control, Change Control :

  • Applies solid understanding of quality system elements from product inception through launch and on-market support
  • Reviews and provides input on the following documentation:
    • Planning documents
    • User needs, product requirements, design verification and validation protocols/records, risk management documentation, design outputs
    • Change impact assessments for products in development and on market
    • Supplier change notifications

** Manufacturing :

  • Reviews and provides input on the following documentation:
    • Non-conforming material reports, reworks, repairs, use-as-is dispositions
    • Process qualification and validation protocols
    • Work instructions and test procedures
  • Analyzes manufacturing data for trends and makes suggestions to address trends

Conduct quality-related activities to deliver consistent; high quality documents; services; products and processes

  • Receives general direction and exercises considerable discretion to own work detail.
  • Recommends possible solutions.
  • Ensures compliant documentation; carrying out tasks related to area of responsibility with management oversight.
  • Decisions may have short- and long-term impact

EDUCATION AND EXPERIENCE, YOU'LL BRING:

Required:

  • Bachelor's degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience.
  • Must have design control/change control and manufacturing
  • At least 5 years work experience in Quality or related field experience;
  • Less experience may be appropriate with advanced degree

Preferred:

Preferred experience in the Healthcare industry.

Preferred experience in medical device manufacturing and working with third party manufacturers.

Has a history of completing successful projects and driving positive compliance outcomes .

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 (Include for Manufacturing roles only)
  • Production areas that are clean, well-lit and temperature-controlled (Include for Manufacturing roles only)
  • 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 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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