Complaint Investigator

Company Overview:

Process Alliance is a leading engineering consultancy firm dedicated to delivering innovative solutions in engineering, automation, manufacturing services, and medical devices. With a commitment to being a better model of problem solving, we have been at the forefront of providing cutting-edge engineering services to clients across the life science industry. Our team of experts thrives on solving complex challenges and driving technological advancements to meet the evolving needs of our clients.

Overview:

We are looking for a quality-focused professional to support Complaint Investigations and quality system activities within a regulated pharmaceutical or medical device manufacturing environment. This role will partner with cross-functional teams to investigate product complaints, evaluate trends, and support continuous improvement initiatives related to product quality and compliance.

Key Responsibilities

• Lead and document investigations associated with product complaints involving pharmaceutical, medical device, and combination products
• Initiate and support quality system records including investigations, trend assessments, action items, and corrective activities
• Analyze complaint and process data to identify recurring trends and support product performance monitoring
• Manage assigned investigations and quality-related tasks to ensure timely completion and compliance with internal expectations
• Work closely with manufacturing, engineering, quality, and technical teams to gather information and drive investigations to closure
• Review and assess incoming complaint information to support daily intake and prioritization activities
• Prepare routine and ad -hoc reports summarizing complaint trends, metrics, and investigation outcomes
• Provide investigation support related to manufacturing operations, packaging processes, and device or combination product systems
• Assist with operational excellence and continuous improvement efforts across quality functions
• Present complaint data, quality metrics, and investigation findings to leadership and internal stakeholders

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Biology, Chemistry, or a related technical discipline preferred
• 3 years of experience within the pharmaceutical, biotechnology, medical device, or other regulated industry environments
• Hands-on experience supporting complaint handling, investigations, CAPAs, or quality systems processes
• Familiarity with manufacturing, validation, packaging, or device assembly operations preferred
• Understanding of applicable regulatory standards such as cGMP, 21 CFR Part 820, ISO 13485, and related compliance requirements
• Strong analytical, organizational, and problem-solving skills with a high level of attention to detail
• Effective communication skills with the ability to collaborate across multiple departments
• Experience using electronic quality management systems such as Veeva, TrackWise, or similar platforms is a plus
• Proficient with Microsoft Office applications including Excel, Word, and PowerPoint

About Our Culture:

At Process Alliance, we strive to be a better model for how problems are solved, and solutions are delivered. We believe in providing a supportive and inclusive work environment where employees can thrive both personally and professionally. Join our team and be part of a company that is shaping the future of engineering solutions.

Qualified applicants must be authorized to work in the United States on a full-time basis. Process Alliance will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Learn more about us:

Visit our website at www.processalliance.com to explore our projects, expertise, and the impact we make in the engineering and consultancy space.

Process Alliance is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences.