Senior Quality Complaints Investigator (Medtech)

TL;DR

Senior Quality Complaints Investigator (Medtech): Managing and investigating customer product complaints and reporting to regulatory agencies with an accent on risk evaluation, trend analysis, and regulatory compliance. Focus on leading complex investigations, ensuring adherence to FDA and ISO standards, and driving process improvements in complaint handling.

Location: Hybrid: Must be based in Libertyville, IL, US (minimum 4 days per week in office). Sponsorship to work in the US is not available.

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

Company

Independent, employee-owned company that develops and manufactures innovative healthcare products for ostomy, continence, and critical care worldwide.

What you will do

• Conduct and lead complex investigations into customer complaints and product performance, including serious incidents and potential recalls.
• Evaluate potential risks associated with complaints and identify patterns to proactively address product issues.
• Draft and file adverse event reports with regulatory authorities in accordance with applicable country regulations.
• Collaborate with product development and manufacturing teams to assess product design, manufacturing processes, and quality control.
• Develop and lead training for associates on complaint management and documentation in SFDC and SAP.
• Support internal and external audits and assist in the development and updating of SOPs related to complaint handling.

Requirements

• Bachelor’s Degree with 5-8 years of related experience.
• Must have valid US work authorization (sponsorship not available).
• In-depth understanding of medical device regulations such as FDA 21 CFR Part 820, 803, 806, ISO 13485, and EU MDR.
• Proficiency in maintaining and analyzing data using Excel, SAP, or HRIS systems.
• Ability to travel and perform customer visits.
• Strong analytical, problem-solving, and organizational skills.

Nice to have

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

Culture & Benefits

• Hybrid work environment with a focus on in-office collaboration (4 days/week).
• Comprehensive health and welfare benefits, including medical, prescription, dental, vision, and disability insurance.
• 401(k) Retirement Savings Plan with auto-enrollment and safe harbor matching contributions.
• Generous paid time off: 11 paid holidays, vacation based on service, and statutory sick days.
• Additional perks including education assistance and adoption assistance benefit programs.