Quality Assurance Specialist

Job Title : Quality Assurance Specialist Medical Devices

Location : CA

job Summary :

The Quality Assurance Specialist will be responsible for ensuring that the company's medical device products meet established quality standards and comply with regulatory requirements.

This role involves monitoring, inspecting, and testing processes and products throughout the development and manufacturing lifecycle.

The QA Specialist works closely with cross-functional teams to maintain compliance with ISO 13485, FDA regulations, and other applicable standards.

Key Responsibilities :

Compliance and Regulatory Standards :

Ensure that all medical devices meet regulatory requirements (FDA 21 CFR Part 820, ISO 13485, EU MDR, etc.).

Stay up to date with industry regulations and standards and assist in implementing updates as needed.

Coordinate with Regulatory Affairs to ensure regulatory requirements are addressed in all quality management processes.

Document Control and Auditing :

Maintain and manage quality system documentation, including SOPs, work instructions, and forms.

Conduct internal audits of the quality system and support external audits (e.g., FDA inspections, ISO audits).

Ensure proper documentation for CAPA (Corrective and Preventive Actions) and non-conformances.

Process Improvement :

Collaborate with production, R&D, and engineering teams to identify quality issues and implement corrective actions.

Lead root cause analysis and implement preventive actions to mitigate quality risks.

Assist in the development and validation of manufacturing processes to ensure consistent product quality.

Quality Control :

Monitor the quality of raw materials, in-process products, and finished devices through inspection and testing.

Develop and maintain quality control procedures, including sampling plans and testing protocols.

Oversee the calibration and maintenance of test equipment and ensure compliance with quality system requirements.

Supplier Quality Management :

Conduct supplier audits to ensure compliance with company standards and regulatory requirements.

Work with suppliers to address non-conforming materials and implement corrective actions.

Training :

Provide training to staff on quality management system (QMS) processes, SOPs, and regulatory requirements.

Develop and deliver quality-related training programs for internal teams.

Qualifications : Education :

Education :

Bachelor’s degree in engineering, Life Sciences, or related field. A Master’s degree or professional certifications (CQE, CQA) are preferred.

Experience :

Minimum 3-5 years of experience in Quality Assurance in a medical device environment.

Thorough knowledge of FDA regulations, ISO 13485, and other applicable regulatory standards.

Experience with CAPA processes, risk management (ISO 14971), and validation activities.

Skills :

Strong attention to detail and analytical skills.

Excellent verbal and written communication abilities.

Proficiency in quality management software and tools.

Ability to work independently and as part of a cross-functional team.

Strong problem-solving skills and ability to lead teams through root cause analysis.