Project Manager (Complaint Investigation) / Senior Quality Specialist

LVI Associates; Indianapolis (IN); On-site; USD 70,000 - 80,000; Full time

Job summary

A prominent organization in the life sciences is seeking a Project Manager / Senior Quality Specialist to lead complaint investigations. This role demands an experienced quality professional responsible for ensuring compliance with regulatory standards and managing complex product issues while providing technical guidance to junior staff.

Benefits

Comprehensive health, dental, and vision insurance

Company-paid life and disability coverage

401(k) with employer match

Paid time off, holidays, and sick leave

Tuition reimbursement and professional development support

Employee recognition and referral programs

Qualifications

• 5-8 years of relevant experience in quality assurance or complaint handling.
• Strong knowledge of FDA cGMP, ISO 13485, and ISO 9001 standards.
• Demonstrated ability to produce high-quality documentation.

Responsibilities

• Lead and approve complaint investigations in alignment with regulatory standards.
• Conduct product assessments and maintain complaint records.
• Ensure timely resolution of complex product issues.

Skills

Regulatory compliance

Root cause analysis

Cross-functional collaboration

Documentation

Leadership

Education

Quality certification from a recognized organization

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

TrackWise

Job description

Project Manager (Complaint Investigation) / Senior Quality Specialist

Project Manager (Complaint Investigation) / Senior Quality Specialist

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Direct message the job poster from LVI Associates

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

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
  
  
  
  
  
  
  
  
  
  
  
  
  

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Industries

  Automation Machinery Manufacturing

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