EPM Scientific are looking for a experience Quality professional to fill a vacancy on a 1 year contract for a Medical Device client of ours! The Quality Engineer will play a critical role in ensuring the quality and compliance of our medical devices. This position involves working closely with cross-functional teams to develop, implement, and maintain quality systems and processes that meet regulatory requirements and industry standards.
Key Responsibilities:
- Develop and implement quality assurance protocols and procedures.
- Conduct risk assessments and failure mode and effects analysis (FMEA).
- Perform root cause analysis and implement corrective and preventive actions (CAPA).
- Ensure compliance with FDA regulations, ISO 13485, and other relevant standards.
- Participate in internal and external audits.
- Collaborate with design and manufacturing teams to ensure product quality.
- Review and approve design control documentation.
- Monitor and analyze quality metrics and trends.
- Provide training and support to staff on quality-related issues.
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- Minimum of 3-5 years of experience in quality assurance within the medical device industry.
- In-depth knowledge of FDA regulations, ISO 13485, and other relevant standards.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Proficiency in quality management software and tools.
- Certification in quality engineering (e.g., CQE) is a plus.
Next Steps:
Forward on your up to date resume and expect to hear back in the coming days!
Kind regards,
