Quality Complaints Investigator

Job Description

Job Description

Quality Complaints Investigator

Kelly® Science & Clinical is seeking a  Quality Complaints Specialist for our client, a leader in the medical device industry, in Clearwater, Florida. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Schedule : On-site Monday through Friday 8am to 5pm
Length of assignment: until end of 2027
Pay: $24-26 an hour
The Quality Complaints Investigator will support the investigation, evaluation, and documentation of customer complaints involving medical-device products. This role will perform detailed product assessments, including visual inspections of returned products and microscopic examinations, while ensuring that all activities comply with current Good Manufacturing Practices (cGMP), ISO 13485, company procedures, and applicable regulatory requirements.
The position will work closely with Quality, Manufacturing, Engineering, Regulatory, Customer Service, and other cross-functional teams to evaluate product concerns, identify potential trends, support root-cause investigations, and ensure complete and accurate complaint records.
Essential Responsibilities
Investigate and evaluate complaints involving returned medical-device products in accordance with approved procedures and regulatory requirements.
Perform visual inspections of returned products to identify defects, damage, contamination, workmanship concerns, labeling issues, or other conditions related to the complaint.
Conduct detailed product inspections under a microscope, when required, to evaluate surface conditions, material defects, particles, foreign matter, assembly concerns, or other abnormalities.
Document inspection findings using photographs, measurements, test results, and clear technical observations.
Review complaint information, product history, manufacturing documentation, test results, and related records to support thorough investigations.
Evaluate returned product against applicable specifications, drawings, procedures, acceptance criteria, and product requirements.
Support the determination of complaint investigation outcomes, including whether a product defect or failure can be confirmed.
Identify potential trends, recurring issues, and adverse quality signals and escalate concerns in accordance with company procedures.
Collaborate with Quality Engineering, Manufacturing, Operations, Regulatory Affairs, Research and Development, and other departments to support root-cause analysis and corrective actions.
Ensure complaint records are complete, accurate, technically sound, and finalized within established timelines.
Enter and maintain investigation details in the applicable electronic complaint-management or quality system.
Support product release, incoming inspection, and other quality-related activities, as assigned.
Provide technical information and supporting documentation during internal audits, notified-body audits, health-authority inspections, and other regulatory reviews.
Follow applicable safety, quality, environmental, and data-integrity requirements.
Maintain organized records and ensure all documentation complies with good documentation practices.
Perform additional quality and product-evaluation activities as assigned by management.
Required Qualifications
Associate degree in a technical, scientific, engineering, or related field.
Minimum of 2-4 years of experience in the medical-device, pharmaceutical, biotechnology, or other regulated manufacturing environment; equivalent education and experience may be considered.
Experience with complaint handling, returned-product evaluation, quality investigations, product inspection, or post-market surveillance.
Experience performing detailed visual inspections, including inspections using a microscope or other magnification equipment.
Experience reviewing batch records, device history records, manufacturing records, inspection records, or related quality documentation.
Working knowledge of cGMP, ISO 13485, quality systems, and applicable medical-device regulations.
Ability to interpret product specifications, drawings, procedures, work instructions, and acceptance criteria.
Strong technical writing, investigation, documentation, and communication skills.
Ability to manage multiple investigations and priorities while meeting established deadlines.
Strong attention to detail and sound judgment when evaluating product and quality information.
Ability to work independently with limited supervision and collaborate effectively with cross-functional teams.
Proficiency with Microsoft Office and electronic quality-management or complaint-management systems.
Preferred Qualifications
Bachelor’s degree in engineering, science, quality, or a related field.
Experience in ophthalmic, surgical, diagnostic, pharmaceutical, or other medical-device manufacturing.
Experience with root-cause analysis, CAPA, nonconformance investigations, risk management, and complaint trending.
Familiarity with FDA regulations, MDR requirements, audit support, and post-market surveillance processes.
Experience using microscopes, inspection equipment, measurement tools, or laboratory testing equipment.
Knowledge of electronic batch records, ERP systems, or quality-management software.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

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