Quality Assurance Manager

Top Quality Recruitment (TQR); Monroe Township (Bradford County); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading company in the medical device industry is seeking a QA Manager to oversee quality assurance processes and ensure compliance with regulatory standards. The ideal candidate will have a strong background in quality assurance, with experience in the medical device sector and a focus on continuous improvement. This role offers a dynamic work environment with opportunities for professional growth and development.

Qualifications

• Experienced Quality Assurance professional with 5-7 years in the medical device industry.
• Focus on audit response, CAPA, validation, and document control within ISO 13485-compliant environments.

Responsibilities

• Monitor and achieve department metrics and cycle times.
• Support document complaint investigations and evaluate trends.
• Ensure compliance with cGMP/USP/ISO and FDA regulations.

Skills

Analytical knowledge

Documentation skills

Education

Bachelor's degree in Biomedical Engineering, Biotechnology, or related field

ISO 13485 Internal Auditor certification

RCC-MDR or equivalent regulatory training

Job description

23 hours ago Be among the first 25 applicants

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.

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.

Are you looking to hire? Get started here:

https://www.topqualityrecruitment.com/fill-a-position/

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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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance, Management, and Manufacturing

• Industries

  Medical Equipment Manufacturing and Pharmaceutical Manufacturing

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