About Careertakes

👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, a diagnostics & healthcare solutions company.

Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.

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What You’ll Do

• Support daily quality assurance (QA) operations including document control, change control, training tracking, and CAPA management.
• Review and approve production records, quality documentation, and process deviations to ensure compliance with internal SOPs and applicable regulations.
• Assist with preparation for and responses to internal and external audits; prepare records, reports, and audit responses as needed.
• Maintain and archive Standard Operating Procedures (SOPs), control document versions, and enforce document retention processes.
• Coordinate and track employee quality and regulatory compliance training; ensure training records are complete and accurate.
• Support investigations of non-conformances and complaints, perform root cause analysis, and help implement corrective and preventive actions.
• Collaborate cross-functionally with QC, Production, and Regulatory teams to resolve quality issues and improve processes.

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Qualifications

• Bachelor’s degree in a scientific, engineering, or related field.
• 0–5 years of experience in Quality Assurance within a regulated environment; experience with ISO 13485, FDA QSR, or GMP is preferred. Recent graduates with relevant coursework/experience are encouraged to apply.
• Fully bilingual in Korean and English (written and verbal).
• Authorized to work in the U.S. without visa sponsorship.
• Strong attention to detail, good problem-solving skills, and proficiency with MS Office (Word, Excel, Outlook).
• Excellent communication skills and ability to work collaboratively across functions.

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Preferred / Nice-to-Have

• Hands-on experience with document control systems or electronic quality management systems (eQMS).
• Previous exposure to medical device or diagnostics quality systems.
• Basic understanding of CAPA lifecycle, audit processes, and regulatory submission support.

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Compensation (Estimated)

• Estimated base: $55,943 per year (estimated figure provided by source). Actual compensation will be determined by Confidential Client and may vary based on experience and location.

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Additional Notes & Compliance

• Confidential Client is committed to a fair hiring process and reasonable accommodation for applicants with disabilities. If you require an accommodation during the hiring process, please notify the recruiter or Careertakes.
• This role is located in Five Corners, NJ. Applicants must follow all state and federal employment eligibility and verification requirements.

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Equal Opportunity & Hiring Transparency

Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.

If you have questions about how your data is used, please contact us directly.