Job Title: Quality Engineer for Medical Device

Job Summary: We are seeking a highly motivated and experienced Quality Engineer to join our team in the Medical Device industry. The Quality Engineer will be responsible for ensuring that all quality related activities comply with regulatory and industry standards, as well as ensuring that the company's products meet or exceed customer expectations. The successful candidate will have experience in the Medical Device industry, with knowledge of quality system regulations, and a proven track record of successful implementation of quality improvement initiatives.

Key Responsibilities:

• Develop, implement, and maintain the company's quality management system, including policies, procedures, and documentation.
• Ensure that all quality related activities comply with regulatory and industry standards such as ISO 13485, 21 CFR Part 820, and other applicable regulations.
• Manage and lead quality improvement initiatives, including risk assessments, root cause analysis, corrective and preventive actions, and process improvement.
• Conduct internal audits to ensure compliance with quality management system requirements.
• Collaborate with cross-functional teams to develop and implement product design and development processes, including risk management and design controls.
• Provide guidance and support to manufacturing and engineering teams to ensure compliance with quality standards and regulatory requirements.
• Monitor and analyze quality metrics to identify areas for improvement and develop action plans to address issues.
• Conduct supplier evaluations and audits to ensure compliance with quality standards and regulatory requirements.
• Participate in external audits and inspections, including FDA inspections, and ensure compliance with audit requirements.

Qualifications:

• Bachelor's degree in Engineering, Science, or a related field.
• 3-5 years of experience in the Medical Device industry, with knowledge of quality system regulations such as ISO 13485 and 21 CFR Part 820.
• Experience in quality management system development, implementation, and maintenance.
• Strong knowledge of quality improvement methodologies such as Six Sigma, Lean, and DMAIC.
• Experience in conducting internal audits and managing corrective and preventive actions.
• Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Knowledge of statistical analysis tools and techniques.
• Familiarity with risk management and design control processes.
• Experience in conducting supplier evaluations and audits.
• Experience in participating in external audits and inspections.

Machines & technologies you'll use:

• CAD Software
• Quality Control Software
• CAM Software

Salary info:

$25 - $38 / hr