Product Complaints Investigator II - Medical Device

First Shift (Days)

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

• 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

Greenville, NC

• Must be legally authorized to work in the United States WITHOUT SPONSORSHIP OF ANY KIND NOW OR IN THE FUTURE.
• Must be able to pass a comprehensive background check, which includes a drug screen.

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.

• 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.

Associate’s or Bachelor’s degree in health science, life science, engineering, or related discipline and a minimum of 4 years of work 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.

• 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.

• Requires standing, walking, lifting up to 35 pounds, manual dexterity, prolonged computer use, and ability to work in office/manufacturing environments.