Hamilton Medical was founded in 1983 with a clear mission: to enhance the lives of patients on respirators and support the caregivers who serve them. Our focus is on developing ventilation technologies that prioritize safety, effectiveness, and lung protection. We are dedicated to easing the burden on healthcare professionals who work tirelessly every day, helping critically ill patients recover and regain their health. We are committed to helping medical teams deliver the best respiratory care ‑ to anyone, anywhere.

The Quality Engineering Supervisor ensures compliance to existing procedures and regulations through document review audits and facilitation of risk data and root cause analysis.

 

Responsibilities: 

• Oversee and manage the quality assurance processes and personnel to ensure compliance with industry standards, regulations, and internal quality policies.
• Lead a team of quality engineers and technicians, providing guidance, training, and support to ensure their professional development and performance.
• Implement quality assurance strategies, policies, and procedures to promote a culture of quality excellence throughout the organization.
• Develop and maintain Quality goals and objectives which align with company quality and risk policy.
• Coordinate internal audits, inspections, and performance evaluations to identify potential quality issues and implement appropriate corrective actions.
• Collaborate closely with cross-functional teams, such as manufacturing, facilities, and customer service, to identify areas for improvement and drive continuous quality improvement initiatives.
• Analyze data and metrics to monitor quality trends, identify root causes of nonconformities, and implement preventive measures to enhance product quality and reliability.
• Ensure timely and accurate resolution of quality- related customer complaints and implement measures to address customer feedback.
• Ensure timely communication to competent authorities pertaining to (Field Corrective
• Actions, Medical Device Reporting, audit findings, etc.)
• Responsible for all productions activities (Start of Production (SOP), validations and qualifications (IQ, OQ, and PQ), line performance, product inspection, and Device History record (OHR).
• Promote best in class supplier performance through, supplier evaluation, supplier audits,
• Supplier Corrective Actions (SCARs), and ensuring supplier agreements are implemented and maintained

• Strong knowledge of quality management systems, regulations, and standards (e.g., ISO 13485, ISO 14971, FDA QSR, etc.).
• Proven experience in leading and managing a team of quality professional
• Excellent problem-solving and analytical skills, with the ability to identify and resolve complex quality issues.
• Strong understanding of statistical techniques and tools used in quality engineering.
• Exceptional communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and interface with customers.

• Bachelor's degree in engineering or a related field (required).
• Advanced degree in quality engineering, industrial engineering, or a related field (preferred).
• Minimum of 3 years of experience in quality engineering, preferably in the medical device industry. 1-2 years’ experience with Master's degree
• Experience in managing a team of quality professionals preferred.

• Diverse portfolio of exciting and innovative design projects
• Tremendous opportunities for professional growth and advancement
• Commitment to sustainable design
• Competitive compensation
• Excellent benefits (medical, dental, vision insurance, paid sick time, paid vacation time, disability insurance, 401k, tuition reimbursement and more)
• Solid stable company
• Drug-free workplace.