Overview:
We’re looking for an experienced Senior Quality Engineer to lead our quality assurance efforts in the development and manufacturing of medical devices. The ideal candidate will play a key role in ensuring compliance with regulations, driving process improvements, and maintaining the highest standards of product quality and safety.
Responsibilities:
Lead the design, implementation, and improvement of quality assurance processes and systems for medical device development and manufacturing.
Collaborate with cross-functional teams to develop and execute comprehensive test plans, ensuring the performance, reliability, and safety of medical devices.
Conduct risk assessments and establish mitigation strategies to ensure compliance with regulatory requirements (e.g., FDA, ISO standards).
Oversee the investigation of quality issues, implementing corrective and preventive actions (CAPA) to drive continuous improvement.
Serve as a subject matter expert in quality assurance, providing guidance and mentorship to junior team members.
Lead and participate in audits, both internal and external, ensuring adherence to quality standards and regulatory requirements.
Stay abreast of industry trends, regulations, and best practices to continually enhance the quality engineering processes.
Requirements:
Bachelor’s degree in Engineering or related field; advanced degree preferred.
4+ years of experience in quality engineering within the medical device industry.
Expertise in quality management systems (QMS) and regulations governing medical device manufacturing (FDA, ISO, etc.).
Proven track record of implementing and improving quality assurance methodologies and processes.
Strong analytical skills with the ability to drive data-driven decisions and problem-solving.
Excellent communication and leadership skills to effectively collaborate with multidisciplinary teams.
Benefits:
Competitive compensation and benefits package.
Opportunities for professional development and career growth.
A collaborative and innovative work environment focused on excellence.
Health and wellness programs.
Flexible work arrangements (if applicable).