Quality Control Specialist

Job Description

Job Description

Quality Control Specialist

Quality Control Specialist

Position Overview
We are seeking a detail-oriented Quality Control Specialist to ensure the safety, reliability, and compliance of medical device products. The role will support production and quality systems by performing inspections, testing, and documentation in accordance with FDA regulations, ISO standards, and Good Manufacturing Practices (GMP). The ideal candidate will help maintain product quality, drive continuous improvement, and support audits and corrective actions.

Key Responsibilities

• Perform incoming, in-process, and final inspections and testing of medical devices to verify conformance with specifications and quality standards.
• Execute and document quality control tests using established procedures, test methods, and measurement equipment.
• Maintain accurate quality records, generate inspection reports, and ensure traceability of materials and test results.
• Support internal and external audits, including FDA and ISO-related assessments, and assist with implementing corrective and preventive actions (CAPA).
• Monitor production processes and collaborate with manufacturing, engineering, and supplier teams to identify and resolve quality issues.
• Review and help maintain quality documentation including inspection plans, work instructions, SOPs, and nonconformance reports.
• Calibrate, maintain, and validate QC equipment and test fixtures according to GMP and company procedures.
• Participate in continuous improvement initiatives, root cause investigations, and risk assessments to reduce defects and improve product reliability.

Qualifications

• Bachelors degree in life sciences, engineering, quality assurance, or a related field, or equivalent practical experience.
• 2+ years of experience in quality control within the medical device industry or regulated manufacturing environment preferred.
• Working knowledge of FDA regulations (21 CFR), ISO 13485, and Good Manufacturing Practices (GMP).
• Hands-on experience with QC testing methods, inspection tools, and measurement equipment (e.g., calipers, micrometers, gauges).
• Proven ability to document and report quality issues, write nonconformance reports, and support CAPA processes.
• Strong attention to detail, analytical and problem-solving skills, and ability to work independently and in cross-functional teams.
• Familiarity with quality management systems (QMS) and electronic records systems (e.g., ERP, LIMS, or QMS software).
• Excellent communication skills and the ability to support audits, train staff on quality procedures, and interact with suppliers and regulatory bodies.

Benefits

• Comprehensive health, dental, and vision
• 401K
• PTO/Holidays
• Professional development opportunities

- For this position, you must be currently authorized to work in the United States without the need for sponsorship for a non-immigrant visa. This job was first posted by CyberCoders on 07/28/2026 and applications will be accepted on an ongoing basis until the position is filled or closed. Everforth CyberCoders is proud to be an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity or expression, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, status as a crime victim, disability, protected veteran status, or any other characteristic protected by law. Our hiring process includes AI screening for keywords and minimum qualifications, and a virtual recruiter as part of the application process. A human recruiter reviews all results. Click here for details on our virtual recruiter . Everforth CyberCoders will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable state and local law, including but not limited to the Los Angeles County Fair Chance Ordinance, the San Francisco Fair Chance Ordinance, and the California Fair Chance Act. Everforth CyberCoders is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. Individuals needing special assistance or an accommodation while seeking employment can contact a member of our Human Resources team at [email protected] to make arrangements.

Salary

$60000 - $65000 USD per year