Quality Engineer Consultant

We are seeking an experienced Quality Engineer to join a client of EPM Scientifics team in the medical device industry. The ideal candidate will have over 5 years of experience in quality engineering, with a strong background in ensuring compliance with regulatory standards and improving product quality. This role involves working closely with cross-functional teams to maintain and enhance our quality management system (QMS) and ensure the highest standards of safety, efficacy, and reliability for our medical devices.

Key Responsibilities:

• Develop and implement quality control procedures to ensure product quality and consistency.
• Conduct risk assessments and failure mode and effects analysis (FMEA) to identify and mitigate potential issues.
• Oversee the validation and verification of manufacturing processes and equipment.
• Analyze quality data and trends to identify areas for improvement.
• Collaborate with cross-functional teams, including engineering, manufacturing, and regulatory affairs, to address quality-related issues.
• Ensure compliance with relevant regulations and industry standards, such as FDA regulations and ISO 13485.
• Manage non-conformances through root cause analysis and corrective and preventive actions (CAPA).
• Provide quality engineering support for new product development and changes to existing products.
• Utilize quality tools, including statistical techniques, six-sigma, and design of experiments (DOE).

Qualifications:

• Bachelor's or master's degree in engineering, science, or a related field.
• Certified Quality Engineer (CQE) certification from the American Society for Quality (ASQ) is preferred.
• Over 5 years of experience in quality assurance, quality control, or regulatory affairs in the medical device industry.
• Strong understanding of FDA regulations, ISO 13485, and other relevant standards.
• Proficiency in statistical process control, design of experiments, and other quality management tools.
• Experience in validating and qualifying manufacturing processes and equipment.
• Excellent problem-solving skills and attention to detail.
• Strong communication and collaboration skills.