Senior Quality Engineer
Rockford, IL- Onsite.
Long Term Contract
Position Summary: We are seeking a Senior Quality Engineer to join our team. The ideal candidate will be responsible for ensuring that our medical devices meet regulatory standards and quality expectations. You will lead quality assurance initiatives, conduct risk assessments, and collaborate with cross-functional teams to enhance product quality throughout the development lifecycle.
Key Responsibilities:
- Develop, implement, and maintain quality assurance processes and procedures for medical devices.
- Conduct risk management activities in accordance with ISO 14971 and other applicable standards.
- Lead and participate in internal and external audits, ensuring compliance with FDA regulations and ISO standards.
- Review and approve design control documentation, including design inputs/outputs, verification, and validation protocols.
- Analyze product performance data and conduct investigations into non-conformances, implementing corrective and preventive actions (CAPA).
- Collaborate with R&D, manufacturing, and regulatory affairs teams to ensure quality standards are met at all stages of product development.
- Provide training and guidance to team members on quality management systems and regulatory compliance.
- Monitor industry trends and changes in regulations to ensure ongoing compliance.
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, or a related field; advanced degree preferred.
- Minimum of 5 years of experience in quality engineering within the medical device industry.
- Strong knowledge of FDA regulations, ISO 13485, and other relevant quality standards.
- Experience with risk management methodologies and tools.
- Proficient in quality tools such as root cause analysis, FMEA, and statistical process control (SPC).
- Excellent analytical, problem-solving, and communication skills.
- Ability to work collaboratively in a fast-paced, cross-functional environment.
