10 Feb
Sr. Quality and Compliance Specialist
Texas, Irving 00000 Irving USA

Vacancy expired!

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 103,000 colleagues serve people in more than 160 countries.Would you like to go to bed every night knowing the work you do improves the health care of millions across the globe? That’s the feeling I get after helping ensure the immunoassay and clinical chemistry in vitro diagnostic products developed and manufactured right here in Dallas/Fort Worth meet the needs of numerous stakeholders (most important is the patient!).Abbott is looking for someone who is passionate about compliance, quality systems, and problem solving. We’re looking for someone who is eager to collaborate across departments, small teams, and large teams to continuously improve the quality of our products and processes. We’re looking for someone who is motivated to deliver and excited to learn from others in the in vitro diagnostics industry. This position will join a team of quality system experts to support the site as a center of excellence in instrument design and manufacturing.If the things we’ve mentioned interest you, and you are looking for a sense of satisfaction in the work you perform, Abbott Diagnostics has a position for you.Main Responsibilities:Identify internal requirements and external regulations, guidances, and standards applicable to the site’s quality systems

Interpret changes and incorporate for use in Abbott business processes

Identify areas of potential impact within Abbott and educate functional areas on quality system requirements

Participate across the business unit to standardize Abbott quality system policies and procedures

Review and update the Quality System Manual and applicable Internal Quality Agreements as needed

Contribute to development and maintenance of site inspection readiness plan and support mitigation of site risks as applicable

Conduct facility walkthroughs to assess area compliance to site procedures and applicable external regulations and standards

Ensure effective implementation of mitigation plan(s)

Facilitate internal and external assessments to evaluate progress of inspection readiness plan

Provide Quality System training as needed, including new hire onboarding and focused training topics as applicable Facilitate inspection planning including logistics of front and staging room, facility and SME readiness, and correspondence with inspectors as needed Provide resource and strategy support during internal and external quality system audits including staging room support and Subject Matter Expert as needed Facilitate local completion of internal and external audit requests needed by other ADD sites Cultivate a wide range of internal networks to facilitate completion of quality system improvement projects Provide Quality System expertise to cross functional teams as neededEducation:Bachelor’s degree in Life Sciences, Technology, Engineering, or Regulatory Affairs is preferred.Qualifications:

Minimum 5 years’ experience in Quality Assurance, Quality Control, or Regulatory Affairs

Previous experience with regulatory interface and prior audit experience required

Working knowledge of ISO/EU standards and FDA Quality System Regulations required

History of completing successful projects and driving positive compliance outcomes

Ability to work in a dynamic and fast paced environment

Must be a strong communicator with peers, team members, and management

Familiarity with In vitro Diagnostic or Hematology products a plus

Previous experience with quality system engineering a plus

An Equal Opportunity EmployerAbbot welcomes and encourages diversity in our workforce.We provide reasonable accommodation to qualified individuals with disabilities.To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

Vacancy expired!


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