Quality Assurance Specialist

Job Summary:

The Quality Assurance Specialist I supports quality operations through product complaint investigations, laboratory testing, documentation review, and regulatory compliance activities. This role is responsible for evaluating complaint samples, conducting routine to moderately complex testing, documenting findings, and ensuring adherence to quality and laboratory standards. The ideal candidate possesses strong analytical abilities, laboratory experience, and a commitment to maintaining compliance within a regulated environment.

Key Responsibilities:

• Perform product complaint documentation, investigations, and review of non-medical complaint records

• Conduct routine to moderately complex laboratory testing and evaluate results in accordance with established procedures

• Support product complaint investigations by performing test methods and documenting findings accurately

• Ensure all complaint documentation complies with Good Documentation Practices, Good Manufacturing Practices, and Good Laboratory Practices

• Identify and initiate appropriate exception documentation while supporting investigation activities

• Assist with document updates, procedural revisions, and continuous improvement initiatives

• Manage multiple assignments effectively while meeting quality and business objectives

• Interpret test data and determine conformance with established specifications and procedures

• Troubleshoot laboratory instruments and analytical techniques as needed

• Maintain laboratory safety, compliance standards, training requirements, and laboratory records

• Support broader team goals and contribute to quality improvement projects

• Maintain compliance with GxP requirements, laboratory procedures, and quality systems

Required Qualifications:

• Bachelor’s degree in Science, Technology, Engineering, or a related discipline

• Laboratory experience within a regulated environment

• Experience supporting product investigations, testing, or quality assurance activities

• Strong written and verbal communication skills

• Excellent documentation and technical writing abilities

• Strong analytical, problem-solving, and critical-thinking skills

• Ability to manage multiple priorities and work independently

• Knowledge of Good Manufacturing Practices, Good Laboratory Practices, and Good Documentation Practices

Preferred Qualifications:

• Experience within the medical device industry

• Familiarity with complaint handling systems and investigation processes

• Experience reviewing laboratory data and investigation reports

• Knowledge of quality systems and regulatory requirements within healthcare or manufacturing environments

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.

Pay Range: $20/hr to $25/hr