Senior Quality Engineer

AbbottAtlanta, GA
$78,000 - $156,000Onsite

About The Position

The Senior Quality Engineer serves as the quality leader for assigned manufacturing operations and provides technical leadership across quality engineering activities. This role drives quality strategy, mentors quality engineers, leads complex investigations and improvement initiatives, and serves as a key partner to Operations leadership in achieving quality, compliance, and business objectives.

Requirements

  • Bachelor’s degree in Engineering, Science, or related technical field with 5+ years of quality engineering, manufacturing engineering, or related experience; or Master’s degree in Engineering, Science, or related technical field with 3+ years of quality engineering, manufacturing engineering, or related experience.
  • Experience leading complex quality initiatives in a regulated industry.

Nice To Haves

  • Medical device industry experience.
  • ASQ Certified Quality Engineer (CQE) or equivalent ASQ certification.
  • Demonstrated experience mentoring engineers and leading cross-functional teams.
  • Experience supporting FDA inspections and external audits.
  • Strong knowledge of FDA Quality System Regulation, ISO 13485, CAPA, complaints, risk management, and manufacturing quality systems.

Responsibilities

  • Serve as the quality lead for assigned manufacturing operations.
  • Develop and execute quality strategies aligned with business objectives.
  • Identify systemic quality risks and drive sustainable improvements.
  • Lead complex investigations involving complaints, CAPAs, nonconforming material, deviations, and quality events.
  • Provide guidance and technical oversight for quality engineering activities.
  • Drive application of risk-based decision making and quality engineering principles.
  • Mentor and develop Quality Engineers.
  • Provide coaching and technical guidance to support team growth.
  • Lead quality engineering activities across cross-functional teams.
  • Lead high-impact quality improvement initiatives.
  • Utilize data analysis and quality metrics to identify trends and drive actions.
  • Champion operational excellence and quality culture initiatives.
  • Lead interactions supporting internal audits, external audits, and regulatory inspections.
  • Ensure compliance with applicable regulations, standards, and company procedures.
  • Assess quality system effectiveness and recommend improvements.
  • Partner with Operations, Manufacturing Engineering, Regulatory Affairs, R&D, Supply Chain, and leadership teams.
  • Present quality performance, risks, and recommendations to management.

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 a 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.
  • Health and wellness benefits
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