Quality Engineer (Medical Device)

We are seeking an experienced Quality Engineer for Medical Devices to join our team. The successful candidate will be responsible for ensuring that our medical devices meet the quality standards required by regulatory agencies such as the FDA, ISO, and other governing bodies. The Quality Engineer will work closely with cross-functional teams, including manufacturing, engineering, and quality assurance, to develop and implement quality control procedures and ensure compliance with industry standards.

Responsibilities

• Develop and implement quality control plans and procedures, including documentation, training, and auditing processes.

• Conduct risk assessments to identify potential hazards and to ensure that products meet safety requirements.

• Participate in product design and development, reviewing product specifications, and collaborating with cross-functional teams to ensure quality is built into products from the beginning.

• Provide guidance and support to manufacturing teams to ensure that products are produced according to established procedures and quality standards.

• Investigate and resolve quality issues, including identifying root causes, developing corrective action plans, and implementing preventative measures.

• Conduct statistical analysis of quality data to identify trends and opportunities for improvement.

• Ensure compliance with regulatory requirements, including FDA regulations, ISO standards, and other applicable regulations.

Qualifications

• Bachelor's degree in engineering or a related field.

• Minimum of 3 years of experience as a Quality Engineer in the medical device industry.

• Strong understanding of FDA regulations, ISO standards, and other applicable regulations.

•Working knowledge of 21CFR 820, ISO13485, EU-MDR requirements for medical device

• Excellent problem-solving skills with the ability to identify root causes and develop effective corrective and preventative actions.

• Ability to work effectively in cross-functional teams and collaborate with colleagues at all levels of the organization.

·Knowledge of design control and verification/validation processes.

• Familiarity with manufacturing processes and quality control methodologies.