Quality Assurance Specialist
About The Position
Join our team as a Quality Assurance Specialist and play a critical role in ensuring the quality, safety, and reliability of medical equipment that makes a difference in patient care. In this role, you'll help maintain and strengthen our Quality Management System by ensuring products, processes, and documentation comply with ISO 13485, FDA Quality Management System Regulation (QMSR), and other regulatory requirements. Working collaboratively across departments, you'll lead quality initiatives, manage nonconformance and corrective action processes, monitor calibration and quality metrics, and identify opportunities to improve efficiency, reduce defects, and enhance customer satisfaction. If you're passionate about quality, continuous improvement, and making a meaningful impact in a regulated environment, we'd love to have you on our team.
Requirements
- High school diploma or GED required
- 2–3+ years of experience in quality assurance, quality control, or inspection, ideally within medical devices, electronics, or a regulated manufacturing environment.
- Working knowledge of quality management systems (QMS) and inspection documentation practices.
- Ability to read and interpret technical specifications, schematics, and work instructions.
- Strong attention to detail and accurate record-keeping skills.
- Effective written and verbal communication skills for documenting findings and collaborating across teams.
- Must be able to travel 10%-15% (at least once per quarter)
Nice To Haves
- Associate's or Bachelor's degree in a related field preferred.
- Experience with ISO 13485 or FDA 21 CFR Part 820 quality systems.
- ASQ certification (CQA, CQT, or CQI) or equivalent.
- Experience with medical device refurbishment, biomedical equipment, or healthcare technology.
- Familiarity with CAPA and non-conformance.
- Experience with EQMS (Electronic Quality Management System)
Responsibilities
- Conduct calibration monitoring on calibrated equipment.
- Maintain and support the company's quality management system (QMS) in accordance with ISO 13485, FDA QSR (21 CFR Part 820), and other applicable regulatory requirements.
- Create, revise, and maintain quality documentation, including work instructions, inspection checklists, SOPs, and inspection records.
- Support internal and external audits by preparing documentation and evidence of compliance.
- Assist with supplier and vendor quality evaluations as needed.
- Initiate and track non-conformance reports (NCRs) and coordinate root cause analysis with relevant departments.
- Support the corrective and preventive action (CAPA) process, tracking action items through to closure.
- Escalate recurring or high-risk quality issues to the Quality Manager and relevant department leads.
- Track and report quality metrics, including defect rates, inspection results, and CAPA status, to management.
- Recommend process improvements to reduce defects, rework, and returns.
- Participate in cross-functional meetings with Operations, Technical Support, and Sales to communicate quality trends and risks.
- Perform other duties as assigned based on business needs.
Benefits
- Paid time off
- Healthcare insurance (medical dental, and vision coverage)
- Accident insurance, critical illness, and hospital indemnity insurance
- Short term (employee paid) and long-term disability (employer paid)
- 401K plan with company matching
- Continuous learning and development - offering opportunities for training, workshops, and certifications
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
