Job Description

Employment Type: Full-time

Available Positions: 1

Location : On-Site

Application Deadline: June 10, 2025

Summary

The QA Manager will be responsible for monitoring and achieving department metrics and cycle times with adherence and compliance to cGMP/USP/ ISO and FDA guidance and requirements.

Key Activities

• Assure Test Method SIPs, SOPs, Material Specifications, etc. are up-to-date and manuals are current.
• Monitor the effectiveness of training by ensuring the employees are adequately trained to perform their job duties.
• Support document complaint investigations, and evaluate and analyze trends of complaints.
• Assist in the product return for complaint investigation, and replacement processes as needed.
• Evaluate deviations/nonconformities identify appropriate root cause(s) and assess quality impact.
• Support the CAPA process and follow up to ensure the CAPAs implemented are effective.
• Support all remediation and continuous process improvement activities and plans.
• Ensure that all data is organized and archived per appropriate workflows and SOPs.
• Interpret and implement applicable standards, regulations, and QMS documents effectively and accurately.
• Establish, monitor, and improve critical KPIs in the QC lab related to invalid OOS, analyst error, training, testing plans, release metrics, and stability testing.
• Provides support during internal and regulatory audits.
• Gather, trend, and assess data and maintain metrics for Quality Assurance.
• Perform prompt DHR review in compliance with FDA regulations and Good Documentation practices.

Preferred Skills

• Extensive and strong analytical knowledge in performing investigations.
• Good documentation and organization skills.

Educations & Experience

• Bachelor's degree in Biomedical Engineering, Biotechnology, or a related life science or engineering field
• ISO 13485 Internal Auditor certification (preferred).
• RCC-MDR or equivalent regulatory training (preferred).
• Experienced Quality Assurance professional with 5-7 years in the medical device industry, focused on audit response, CAPA, validation, and document control within ISO 13485-compliant environments.

Are you looking for your next opportunity? We can help.

Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible.

TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.

Accommodation for applicants with disabilities is available upon request.

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We thank all applicants for their interest and appreciate the time and effort involved; however, due to the large volume of resumes received only those candidates selected for an interview will be contacted. Please attached your resume to your application.

Job ID: 7822

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