Quality Assurance Expert - Medical Technologies

Our Client:

A groundbreaking company at the forefront of regenerative medicine is seeking a highly qualified and experienced Quality Assurance professional to join their growing team. They are revolutionizing therapeutic delivery with innovative products that address critical needs in the medical field.

The Opportunity:

This is an exciting opportunity to play a pivotal role in ensuring the highest standards of quality and compliance for this industry leader. You will be responsible for establishing and maintaining robust quality systems and processes to support their breakthrough medical technologies, from initial development through to full-scale manufacturing.

Responsibilities:

Lead the development and implementation of comprehensive quality systems and policies, ensuring adherence to regulatory requirements (e.g., 21 CFR 820) and industry best practices.
Conduct risk assessments and implement effective risk management plans to mitigate potential issues.
Oversee all aspects of quality control, including inspections, data analysis, and root cause analysis of non-conformance events.
Provide expert guidance and support to cross-functional teams across R&D, Manufacturing, and other departments.
Lead supplier audits and evaluations, ensuring compliance with quality standards.
Conduct internal audits to identify and address potential quality gaps.
Manage and maintain quality documentation, including standard operating procedures (SOPs) and quality records.
Stay abreast of evolving industry regulations and quality standards.

Qualifications:

Minimum of a Bachelor's degree in a relevant field such as Biomedical Engineering, Chemical Engineering, Biochemistry, or a related discipline.
5+ years of experience in the medical device industry, with a strong understanding of quality assurance principles and practices.
Proven experience in developing and implementing quality management systems (QMS) based on ISO 13485 standards.
Familiarity with relevant regulatory requirements, including 21 CFR 820 and ISO 14971, is a plus.
Experience with statistical techniques and tools for data analysis.
Excellent communication, collaboration, and interpersonal skills with the ability to effectively interact with various levels of management and technical teams.
Strong analytical and problem-solving skills with a focus on detail and accuracy.
Highly motivated and results-oriented with a proactive approach to quality improvement.

Location:

On-site at our client's laboratory. (Specific location will be included in the final job description)

Keywords:

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