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