Project Manager (Complaint Investigation) / Senior Quality Specialist

LS Solutions; Fishers (IN); On-site; USD 70,000 - 80,000; Full time

Job summary

LS Solutions is looking for a Project Manager (Complaint Investigation) / Senior Quality Specialist to lead complex complaint investigations and provide technical guidance. The ideal candidate has extensive knowledge of quality systems and regulations, along with strong project management and communication skills. This full-time role offers an opportunity to significantly impact the quality processes within the consulting industry.

Qualifications

• 5-8 years of relevant experience in Quality or Project Management.
• Demonstrated capability to manage complex complaints.
• Strong project planning and organizational skills.

Responsibilities

• Oversee the complaint investigation process and ensure objectives are met.
• Provide technical guidance and support for multiple projects.
• Review and sign off on completed complaint investigations.

Skills

Interpersonal skills

Communication skills

Project leadership

Quality system principles

Regulatory compliance

Education

Bachelor's Degree or equivalent experience

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

TrackWise

Job description

Project Manager (Complaint Investigation) / Senior Quality Specialist

Be among the first 25 applicants. Direct message the job poster from LS Solutions.

Responsibilities:

This individual will have the regulatory experience to oversee the complaint investigation process and will possess the knowledge and ability to successfully navigate complex complaints. The individual will serve as point of contact to ensure timing/objectives are being met.

• Senior member of the team providing technical guidance to other team members
• Support multiple projects scheduled simultaneously
• Review and sign off on completed complaint investigations
• Provide effectiveness check information as required
• Review and investigate complaint information provided
• Perform visual/functional assessments as required
• Utilize TrackWise to record and document Complaint History
• Research Deviation, Batch Record Review, Design History File/FMEA Review, Product Safety Assessment, and Product Impact Evaluation background information pertaining to complaints
• Contact data stewards to gain more insight into complaints and gather data as needed
• Utilize Root Cause Investigation Summary and CAPA Overview to inform investigations
• Author templates for basic and complex complaints
• Use templates to expedite investigation write-ups for future complaints

Requirements:

• Demonstrated capability to deliver on the Senior Quality Specialist responsibilities
• Excellent knowledge of Quality system principles; FDA Quality System Regulations (cGMP); ISO 13485; ISO 9001; and ISO 14971 Risk Management Systems
• Strong interpersonal and communication skills to effectively collaborate and communicate with various levels of the organization
• Experience in project leadership and independently generating high-quality deliverables
• Proficiency in Microsoft Word, Excel, and PowerPoint
• Minimum 5-8 years of relevant experience

Additional Responsibilities:

• Update stakeholders on project progress
• Coach and support project team members

Qualifications:

• Bachelor's Degree or equivalent experience
• Strong project planning and management skills
• Excellent verbal, written, and organizational skills

Seniority level:

Mid-Senior level

Employment type:

Full-time

Job function:

Project Management and Information Technology

Industries:

Business Consulting and Services

Location: Fishers, IN

Salary: $70,000.00-$80,000.00