Project Manager (Complaint Investigation) / Senior Quality Specialist

Indianapolis

Permanent

Negotiable

Automation and Controls

PR/548645_1749569061

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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