Complaint Management Specialist (Spec 2)

About the role

PurposeBD is seeking a Complaint Management Specialist (Spec 2) to lead investigations of product complaints, identify root causes, and drive corrective and preventive actions within a regulated medical‑device environment.

Key responsibilities

• Execute complaint investigations, determine root causes, and implement corrective and preventive actions using problem‑solving methodologies.
• Ensure investigations, engineering tasks, and device history records meet regulatory and internal procedural requirements.
• Collaborate with management and peers to improve processes and remediate audit or inspection findings.
• Escalate product risk assessments to the Risk Management Council and document PRA outcomes.
• Administer the FPM/CPM process, analyze data for trends, out‑of‑control situations, and top offenders.
• Support rollout and training for new CAPA tools, techniques, and process enhancements.
• Drive continuous improvement initiatives aimed at reducing complaint volume.

Required profile

• Bachelor’s degree in industrial engineering, mechanical engineering or a related field.
• Minimum 2 years of experience in complaint management, preferably within the medical‑device or pharmaceutical industry.
• Strong analytical, problem‑solving and interpersonal skills.
• Ability to manage competing priorities in a fast‑paced environment and work both independently and as part of a team.

Required skills

• Knowledge of US Quality Systems Regulation (21 CFR Part 820).
• Familiarity with ISO 13485, JPAL and CMDR standards.
• Proficiency with Microsoft Office applications.
• Basic understanding of statistical techniques for data analysis.
• Experience with CAPA processes and root‑cause analysis.

What we offer

• Opportunity to work for a global leader in medical technology.
• Engagement in impactful quality initiatives that directly affect patient safety.
• Professional development and training on CAPA and quality systems.