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Abbott

Makes heart devices, glucose sensors and lab tests

Lead Clinical Lab Quality Assurance Specialist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeMadison, WI, USA$86.7k - $173.3k

About the Job

Requirements

  • A bachelor's degree in a scientific major or a field related to the essential duties of the position is required.
  • At least 4 years of professional work experience in quality assurance in a regulated environment is required.
  • At least 3 years of experience developing, establishing, and implementing quality indicators within a laboratory environment is required.
  • At least 2 years of direct experience leading process and project implementation, management, or improvement is required.
  • At least 2 years of experience managing, monitoring, and maintaining Quality Management Systems is required.
  • Demonstrated experience leading quality management meetings with senior leadership, including gathering, analyzing, and presenting key quality metrics, performance indicators, and supporting data to drive discussions and continuous improvement initiatives is required.
  • Demonstrated understanding and professional working knowledge of FDA, CLIA, CAP, HIPAA, or other applicable regulatory entities and standards is required.
  • Proficiency in Epic healthcare software or other electronic patient medical record software or systems is required.
  • Proficiency in Microsoft Office programs is required.
  • Demonstrated aptitude for learning new processes and software is required.
  • Demonstrated ability to collaborate across functions with internal and external stakeholders and communicate ideas and opinions proactively and professionally is required.
  • Exceptional written and verbal communication, attention to detail, and organization skills are required.
  • Ability to perform the essential duties of the position with or without accommodation is required.
  • Authorization to work in the United States without sponsorship is required.

Responsibilities

  • Independently manage multiple complex projects simultaneously within defined timelines, prioritizing as necessary, with minimal instruction or oversight.
  • Identify, develop, design, and assist with coordinating improvements.
  • Provide subject matter expertise, guidance, and recommendations to Lab QA team members and other laboratory teams and sites while leading through influence, informal leadership, and best-practice advocacy.
  • Investigate, document, and resolve complex quality assurance concerns received from laboratory teams, enterprise teams, and third-party vendors.
  • Use project management experience to initiate and lead cross-functional projects with internal and external partners.
  • Interface and work effectively and professionally with all levels of the organization, vendors, and customers.
  • Work in a team environment and adapt effectively to changes in projects, workload, and circumstances, responding quickly to new information.
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
  • Support and comply with company Quality Management System policies and procedures.
  • Maintain regular and reliable attendance.
  • Work on a mobile device, tablet, or computer and perform typing for approximately 80% of a typical working day.
  • Maintain the ability and means to travel between work locations.
  • Maintain confidential information.

Desired Qualifications

  • An advanced degree in a scientific field related to the essential duties of the position is preferred.
  • Experience with or demonstrated understanding of state regulatory requirements for clinical laboratory operations, such as California, New York, Maryland, and Florida, is preferred.
  • Experience with audits or inspections by regulatory bodies, such as CAP, FDA, and/or the New York State Department of Health, is preferred.
  • Additional quality assurance or project management certifications such as Six Sigma or PMP are preferred.
  • Experience developing and maintaining quality indicators, key performance indicators, dashboards, or quality performance reporting in a clinical laboratory, healthcare, diagnostic, or regulated environment is preferred.
  • Strong data analysis and interpretation skills, including identifying trends, emerging risks, recurring issues, and opportunities for continuous improvement, are preferred.
  • Experience investigating nonconformances and adverse quality trends, including root cause analysis, corrective and preventive action, and effectiveness monitoring, is preferred.
  • Demonstrated ability to facilitate quality reviews and communicate complex quality data as clear, actionable insights for leadership and cross-functional stakeholders is preferred.
  • Proven ability to collaborate and lead through influence across functions, driving alignment, accountability, and resolution of quality-related issues, is preferred.

About the Company

Abbott

Makes heart devices, glucose sensors and lab tests

Abbott makes medical devices, diagnostic tests, nutrition products and branded generic drugs for hospitals, laboratories, pharmacies and patients. Its best-known product is the FreeStyle Libre, a coin-sized sensor worn on the upper arm that tracks blood sugar around the clock without routine finger pricks. Its other lines run from heart valves, pacemakers and brain stimulators to lab analyzers, rapid tests and mail-in colon cancer screening kits, and Abbott earns money by selling these products to health systems, labs, retailers and consumers. The company was founded in 1888 by Chicago physician Wallace Abbott and is based in Abbott Park, Illinois.

Company size
10,001+
Company stage
IPO
Headquarters
Abbott Park, IL
Founded
1888

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