Senior Quality Investigator I-II (Medical Device)

TL;DR

Senior Quality Investigator (Medical Device): Performing complaint investigations and trend analysis for healthcare products with an accent on regulatory reporting and product performance. Focus on managing complex complaint investigations, ensuring compliance with FDA and ISO standards, and collaborating with manufacturing teams to improve product design.

Location: Hybrid (Libertyville, IL). Sponsorship to work in the US is not available.

Salary: $61,000 - $90,000 yearly

Company

An independent, employee-owned company that develops, manufactures, and markets healthcare products worldwide, specializing in ostomy, continence, and critical care.

What you will do

• Lead and oversee complex complaint investigations, including those related to serious incidents and potential recalls.
• Perform trend analysis and identify patterns to proactively address product issues.
• Draft and file adverse event reports with regulatory authorities in accordance with country regulations.
• Collaborate with product development and manufacturing teams to assess product design and quality control.
• Develop and lead training for associates on complaint management and documentation in SFDC/SAP.
• Provide support during internal and external audits and update SOPs related to complaint handling.

Requirements

• Bachelor’s Degree with 5-8 years of related experience.
• Must be authorized to work in the US without sponsorship.
• In-depth understanding of medical device regulations (e.g., FDA 21 CFR Part 820, 803, 806, ISO 13485, EUMDR).
• Strong analytical, problem-solving, and organizational skills.
• Ability to travel and perform customer visits.
• Proficiency in Microsoft Office suite.

Nice to have

• Experience in the medical device industry specifically in data analysis, complaints, or CAPA.
• Registered Nurse (RN) certification.
• Experience with ISO 14971.

Culture & Benefits

• Competitive base pay and eligibility for the Hollister Corporate Bonus Plan.
• Comprehensive health and welfare benefits including medical, prescription, dental, vision, and disability.
• 401(k) Retirement Savings Plan with auto-enrollment and safe harbor matching.
• Generous paid time off including 11 paid holidays, vacation based on service, and sick days.
• Education and adoption assistance benefit programs.