Medical Device Quality Assurance Specialist

MedMatch Devices offers a fast-paced and dynamic work environment with opportunities for professional growth and development. This position may require occasional travel to other company locations or to attend industry conferences and events. If you are passionate about ensuring the quality and safety of medical devices and have a strong attention to detail, we encourage you to apply for the Medical Device Quality Assurance Specialist position at MedMatch Devices.

Position Title: Medical Device Quality Assurance Specialist

Company Description: MedMatch Devices is a leading medical device company that specializes in the development, manufacturing, and distribution of high-quality medical devices. Our mission is to improve the lives of patients by providing innovative and reliable medical devices. We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team.

Job Summary: As a Medical Device Quality Assurance Specialist, you will play a crucial role in ensuring the safety, efficacy, and quality of our medical devices. You will work closely with cross-functional teams including R&D, manufacturing, regulatory affairs, and marketing to ensure compliance with all applicable regulations and standards. Your primary responsibility will be to develop and implement quality assurance procedures and processes to ensure the highest level of product quality.

Key Responsibilities:

• Develop and maintain quality assurance procedures and processes in compliance with FDA regulations and ISO standards.
• Conduct internal audits to assess compliance and identify areas for improvement.
• Coordinate external audits and inspections by regulatory bodies.
• Collaborate with cross-functional teams to ensure quality control throughout the product lifecycle.
• Review and approve all product-related documentation, including design and process validation reports, change controls, and risk management documents.
• Investigate customer complaints, non-conformances, and product recalls, and implement corrective and preventive actions.
• Monitor and analyze quality metrics, identify trends, and implement improvement plans.
• Train and educate employees on quality assurance procedures and processes.
• Stay current with industry regulations, standards, and best practices related to medical devices.

Qualifications:

• Bachelor's degree in a relevant field, such as biomedical engineering, quality engineering, or related field.
• Minimum of 3 years of experience in the medical device industry, with at least 2 years in a quality assurance role.
• Knowledge of FDA regulations, ISO standards, and other relevant requirements for medical devices.
• Experience with quality management systems and tools, such as CAPA, risk management, and design controls.
• Strong problem-solving and analytical skills.
• Excellent attention to detail and ability to work independently.
• Excellent communication and interpersonal skills.

Join our team and make a meaningful impact on patients' lives.