Description
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:
Qualifications:
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.