Quality Assurance Associate

About the role

The Quality Assurance (QA) Associate supports the implementation and maintenance of the Quality Management System (QMS) to help ensure product quality and compliance with applicable regulatory requirements, including FDA 21 CFR Part 820, ISO 13485, and internal quality system requirements. This role performs routine quality assurance activities, maintains quality records, and assists with quality-related processes across the organization.

Primary Responsibilities

• Review Device History Records (DHRs) for completeness, accuracy, and compliance with Good Documentation Practices (GDP), following established procedures and escalating discrepancies as needed.
• Assist with the maintenance of the Approved Supplier List (ASL) and supplier qualification documentation, including organizing records and supporting supplier monitoring activities.
• Support the documentation and tracking of nonconforming products, including returns, rework, and scrap activities, ensuring records are complete and issues are escalated for appropriate evaluation and disposition.
• Assist with equipment calibration and preventive maintenance activities by maintaining records, tracking due dates, and following established procedures.
• Support environmental monitoring activities for subcontractor cleanrooms (CER), as assigned.
• Assist with coordinating microbiology testing and monitoring activities and maintaining associated documentation.
• Provide support to Quality Control (QC) Inspectors as needed, including assisting with quality records and related activities.
• Assist with the review of Device History Records (DHRs) and product labeling for completeness and compliance during finished goods quality release activities, following established checklists and procedures.
• Support internal audits by gathering documentation, organizing records, and assisting with follow-up activities as directed.
• Maintain accurate and organized quality records in accordance with applicable procedures and documentation requirements.
• Identify and communicate documentation discrepancies, quality concerns, and potential compliance issues to the appropriate team members or supervisor.
• Follow established quality procedures and contribute to continuous improvement initiatives focused on product quality, safety, and customer satisfaction.
• Perform other related quality assurance duties as assigned.

What Makes You Successful (KSA's)

• Basic understanding of quality assurance principles and Good Documentation Practices (GDP), with the ability to learn and apply applicable quality system requirements.
• Basic familiarity with FDA 21 CFR Part 820, ISO 13485, and quality system requirements in a regulated manufacturing environment, or the ability to develop this knowledge through training.
• Strong attention to detail and the ability to follow written procedures, instructions, and established checklists.
• Proficient in interpreting microbiological laboratory test reports, evaluating results against specifications, and generating comprehensive reports to support product quality, engineering analyses, regulatory compliance, and adherence to applicable industry standards and regulations.
• Ability to establish effective working relationships and collaborate with colleagues across departments.
• Ability to organize tasks, maintain accurate records, and manage assigned responsibilities in a timeline-driven environment.
• Demonstrates professionalism, dependability, and a commitment to quality and compliance.
• Basic proficiency in Microsoft Office applications, including Word and Excel, with the ability to learn additional software systems and tools as needed.
• Ability to recognize routine discrepancies, follow established problem-solving procedures, and escalate issues requiring additional evaluation or judgment.
• Willingness to learn medical device quality processes, including DHR review, nonconforming product documentation, supplier monitoring, calibration, preventive maintenance, and internal audits.

Experience and Education

• Bachelor's degree in a science, engineering, or quality-related field (e.g., Biology, Chemistry, Biomedical Engineering, or similar) is preferred; or an advanced degree; or equivalent work experience.
• Previous professional quality assurance experience is not required; relevant coursework, internships, or exposure to regulated manufacturing environments is a plus.
• Basic familiarity with quality documentation, regulatory requirements, or manufacturing processes is preferred.
• Ability to learn company quality procedures, documentation practices, and applicable regulatory requirements through training and on-the-job experience.

Work Authorization

US Work Authorization required

Work Environment

This job operates 100% onsite.

Travel

15% travel may be required