Project Manager (Complaint Investigation) / Senior Quality Specialist


Indianapolis
Permanent
Negotiable
Automation and Controls
PR/548645_1749569061
Project Manager (Complaint Investigation) / Senior Quality Specialist

Project Manager (Complaint Investigation) / Senior Quality Specialist

A prominent organization in the life sciences sector is seeking a Project Manager / Senior Quality Specialist to lead and manage complaint investigations. This role is ideal for an experienced quality professional with a strong foundation in regulatory compliance, root cause analysis, and cross-functional collaboration.


About the Role

As a senior member of the quality team, you will be responsible for overseeing the complaint investigation process, ensuring timely and thorough resolution of complex product issues. You'll act as a key liaison for internal teams and provide technical leadership to junior staff. The role may involve managing multiple projects concurrently and requires a high level of independence and accountability.


Key Responsibilities

  • Lead and approve complaint investigations in alignment with regulatory standards.
  • Conduct visual and functional product assessments as needed.
  • Maintain complaint records using systems such as TrackWise.
  • Review deviations, batch records, design history files, FMEAs, and product safety assessments.
  • Collaborate with data stewards to gather relevant information and insights.
  • Apply root cause analysis and CAPA methodologies to support investigation outcomes.
  • Develop and maintain templates to streamline future complaint investigations.
  • Provide effectiveness check data and support audit readiness.

Qualifications

  • 5-8 years of relevant experience in quality assurance or complaint handling within regulated industries.
  • Strong knowledge of FDA cGMP, ISO 13485, ISO 9001, and ISO 14971 standards.
  • Proven leadership and communication skills across all organizational levels.
  • Demonstrated ability to produce high-quality documentation and deliverables.
  • Advanced proficiency in Microsoft Word, Excel, and PowerPoint.
  • Quality certification from a recognized organization is required.
  • Must have authorization to work in the United States without the need for current or future sponsorship.

Benefits & Culture

  • Comprehensive health, dental, and vision insurance
  • Company-paid life and disability coverage
  • Health Savings Account (HSA) and Flexible Spending Accounts (FSA)
  • 401(k) with employer match
  • Paid time off, holidays, and sick leave
  • Tuition reimbursement and professional development support
  • Parental and bereavement leave
  • Employee recognition and referral programs
  • Team-building events and a collaborative, inclusive work environment

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