Abbott

Senior Quality Assurance Specialist

Abbott

full-time

Posted on:

Location Type: Office

Location: Portsmouth • Illinois • Virginia • United States

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Salary

💰 $78,000 - $156,000 per year

Job Level

Senior

About the role

  • Responsible for implementing and maintaining an effective Quality System.
  • Leading and/or contributing to system, product and process improvement projects.
  • Independently lead groups and projects to resolve complex issues, analyze complex problems and identify their impact, establish probabilities, draw conclusions reflecting broad business needs and ensure compliance.
  • Cross-functionally lead Quality System process improvements which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation.
  • Contribute to the development, approval and implementation of product labeling and instructions for use as required.
  • Makes timely and effective decisions related to business issues within scope of responsibility; appropriately elevates high risk issues / decisions; identifies and quantifies risks and their consequences relative to the success of a project / task; recommends appropriate action; decisions or recommendations would typically achieve departmental / project objectives.
  • Supporting equipment, process and facility qualification and validation activities as required.
  • Supporting external agency and internal audits as needed.
  • Supporting new product introduction activities.
  • Assisting in product launch and SKU discontinuation activities.
  • Aid in implementing process improvements with respect to Quality Assurance processes.
  • Maintain Quality metrics as required.
  • Provide support (management/execution) with CAPA, change requests, deviations and NCMRs.
  • Work may require collaboration with other Division sites and/or other Abbott divisions.
  • May manage training program.
  • Manage complaints as required.
  • Assist in managing supplier qualification program and support TPM management.
  • Onboard suppliers per established supplier management procedures.
  • Create and revise quality agreements and maintain supplier files.
  • Support in supplier auditing activities.
  • Perform Document Control activities as required.
  • Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.
  • Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
  • Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
  • Perform other duties and projects as assigned.

Requirements

  • BS/BA degree preferably in science or engineering or chemistry, biology, or other scientific discipline
  • Minimum of 5 years of Quality Assurance or Regulatory Compliance experience in a manufacturing environment, preferably in vitro diagnostics or FDA regulated industry with 3-5 years progressively responsible positions
  • Thorough knowledge and practical application of Quality System Regulations 21 CFR 820, ISO 13485, ISO 14971, and IVDD
  • Strong knowledge of MS Office
  • Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor
  • Must be detail-orientated, self-motivated and available for flexible scheduling
  • Strong communication, problem solving and motivational skills
  • Demonstrated initiative and problem-solving skills and critical-thinking skills.
Benefits
  • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
  • An excellent retirement savings plan with high employer contribution.
  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
Quality Systemprocess improvementCAPAquality auditsvalidationequipment maintenanceproduct labelingquality metricsDocument Controlsupplier qualification
Soft skills
problem solvingcommunicationinitiativecritical thinkingdetail-orientedself-motivatedflexible schedulingteam collaborationleadershipdecision making
Certifications
BS/BA degreeISO 13485ISO 1497121 CFR 820