1+ months

Manager, Quality Systems Compliance, Hematology IVD

Santa Clara, CA

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Development of strategic plans, programs, policies, and procedures, which interpret and ensure compliance with quality system regulations/standards. Develop and support a successful compliance strategy that supports Abbott’s growth objectives. Establishes and implements FDA ,ISO, Corporate, and Division requirements into Site level procedures. Identifies compliance gaps and develops site compliance plans. Serves as the quality system representative for the site. Represents the site on division quality system and compliance teams. Represents the site quality systems with external agencies including FDA, ISO, and customer auditing groups. This position shall manage site Quality Systems personnel involved in Internal Auditing, Management Reviews,  CAPA and CAB/MRB coordination, provide leadership and assure prudent decision making processes concerning compliance related issues, advise management of potential risks and offers solutions. This function helps maintain a constructive regulatory compliance position for the site through the early identification, correction and prevention of compliance issues.

Main Responsibilities:

Manage and coordinate site Management Review Board and CAPA Oversight Review Board processes.
Oversee other compliance related projects, site compliance plan initiatives, or site improvements.
Oversight of the administration of the site CAPA system.
Represents Site Quality systems and subsystems during regulatory body and third party audits and inspections.
Examples include FDA,ISO,TGA ,Customer, MDSAP
Coordination of preparation for and facilitation of external and non-site internal audits of the facility (FDA,ISO, Corporate and Division),provide inspection administration support during these inspections/audits/ and coordinate the development and implementation of applicable CAPA's for noted deficiencies.
Develop and support a successful compliance strategy that supports Abbott’s growth objectives.
Develop and staff the annual audit schedule by working with departmental heads.
Review and interpret requirements based on regulations and standards and provide direction through audit reviews, corrective action plan reviews and training of auditors.
Develops strategies to maintain compliance standards and regulations and serves as site Representative on the Division's Compliance Core Team(s) and subteam (s). Involves and informs appropriate site personnel regarding quality system changes and strategy.
Reviews division quality policies and translates requirements into Site level documents.
Reviews and approves site level quality system documents for intent and requirements.


The individual is responsible for ensuring compliance to the Quality Systems Regulation, ISO regulations,etc.,through internal auditing, corrective and preventative actions and ensuring compliance with ADD Quality system through site document control and process ownership review.
The individual interacts frequently with site management with executive responsibility and is a primary contact during FDA / ISO and other third party inspections.
The individual is accountable for integrity of the site Quality System and compliance of site documentation with current approved procedures and QSR requirements.
Strategic and tactical decisions for the Site level quality system procedures will be made based upon the information the individual is given and provides in a management and/or informal setting.
Actions directly impact effectiveness of the Quality System.
A high level of risk and visibility are associated with these activities.


Bachelor Degree required, preferably in a Technical/Scientific area e.g., Chemistry, Physics or Biology, Pharmacy, Microbiology, Medical Technology, Engineering. Masters Degree desired.   A minimum of 8 years experience in Quality Assurance/Quality Control or Regulatory areas, including a minimum 2 years medical device industry experience and a minimum of 2 years supervisory / management experience. Previous experience with regulatory interface and prior audit experience required. Knowledge of ISO/EU standards and FDA Quality System Regulation. Familiarity with In vitro Diagnostic or Hematology products a plus; previous experience with quality system engineering a plus.
Job Family: Quality Assurance
Division: ADD Diagnostics
Travel: Yes, 5 % of the Time
Medical Surveillance: No
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)


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Manager, Quality Systems Compliance, Hematology IVD

Santa Clara, CA

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Santa Clara, CA

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