Product Complaints Investigator II - Medical Device

About the role

Discover Impactful Work: The Product Compliant Investigator II supports the investigation and resolution of product complaints in a regulated pharmaceutical CDMO environment. This role contributes to maintaining compliance with cGMP requirements while protecting product quality and patient safety. Working under general supervision, you will execute complaint investigations of low to moderate complexity, collaborate with cross-functional teams, and develop foundational expertise in complaint handling, root cause analysis, and quality systems.

Responsibilities

• Perform product complaint investigations of low to moderate complexity.
• Collect, document, and assess data supporting root cause analysis.
• Draft investigation reports for review and approval.
• Escalate quality, regulatory, or patient safety concerns promptly.
• Support CAPA implementation and tracking.
• Partner with Manufacturing, QC, Supply Chain, and cross-functional teams.
• Assist with audits, inspections, and customer inquiries.
• Maintain compliance with safety and quality requirements.
• Manage workload while meeting timelines and quality expectations.
• Perform other duties as assigned.

Requirements

• Education: Associate’s or Bachelor’s degree in health science, life science, engineering, or related discipline and a minimum of 4 years of work experience.
• Experience: Minimum of 4 years of experience within combination products or medical device industry; experience conducting GMP investigations involving combination product or medical device complaints, deviations, or quality events strongly preferred; CDMO or manufacturing experience is a plus.
• Eligibility: Must be legally authorized to work in the United States without sponsorship; must be able to pass a comprehensive background check, which includes a drug screen.
• Location: Greenville, NC (relocation assistance not provided).
• Physical Requirements: Requires standing, walking, lifting up to 35 pounds, manual dexterity, prolonged computer use, and ability to work in office/manufacturing environments.

Qualifications

• Working knowledge of cGMP regulations and quality systems.
• Strong written and verbal communication skills.
• Good organizational skills and attention to detail.
• Ability to manage multiple priorities and meet deadlines.
• Self-motivated with willingness to learn and develop technical expertise.
• Works effectively in cross-functional teams.

Benefits

• Medical, Dental, & Vision benefits – effective Day 1
• Paid Time Off & Holidays
• 401K Company Match up to 5%
• Tuition Reimbursement – eligible after 90 days
• Employee Referral Bonus
• Employee Discount Program
• Recognition Program
• Charitable Gift Matching
• Company Paid Parental Leave
• Career Advancement Opportunities

Schedule

First Shift (Days). Work environment adheres to Good Manufacturing Practices (GMP) and safety standards in an office setting.