Quality Engineer

About the Role

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.

Responsibilities

• Ensure compliance to existing procedures and regulations through document review, audits, and facilitation of risk management, data trending, and root cause analysis.
• Analyze production limitations and problems and facilitate root cause analysis.
• Analyze data to draw conclusions for production and quality management.
• Review change orders for product releases/updates and production material and process changes.
• Conduct and document internal non-conformance and customer complaint investigations.
• Support Medical Device Reporting (MDRs), complaints, field corrective action (Recall), and management review meetings.
• Effectively engage in projects as the Quality Engineering resource.
• Formulate or assist in formulating quality standards, policies, programs, plans, procedures, and practices.
• Assess and approve product and process validation activities.
• Perform individual assignments as directed by supervisors and superiors.
• Ensure adequate and continuous controls are exercised over all assigned activities affecting quality.
• Establish and maintain effective work relationships.
• Maintain professional competence, knowledge, and skill necessary for satisfactory performance of all assigned responsibilities.
• Facilitate the completion of Risk Analysis documentation for new and existing products/processes.
• Organize and conduct internal and supplier audits.
• Initiate and manage Corrective/Preventative actions based on data review and input from outside sources and internal data analytics.
• Serve as quality contact during customer and notified body audits.

Requirements

• Able to read and understand engineering design drawings, technical plans, and reports.
• Possess knowledge and hands-on experience with ISO quality system standards ISO 13485, ISO 14971, and FDA 21 CFR 820.
• Auditing education and experience.
• Ability to work effectively with various work groups to assure conformance to quality and regulatory requirements, internal processes, and policies.
• Ability to prioritize tasks in a deadline-driven environment.
• Strong written and verbal communication and organizational skills.

Qualifications

• Bachelor's Degree in Mechanical Engineering, Manufacturing Technology, Business, or related discipline from an accredited university.
• Minimum of 3 years of quality assurance experience.
• Certification in Quality (CQE, CSSBB, CQA) a plus.

Benefits

• Competitive compensation.
• Medical, dental, and vision insurance.
• Paid time off.
• Disability insurance.
• 401k retirement plan.
• Tuition reimbursement.

About Hamilton

• Diverse portfolio of exciting and innovative design projects.
• Tremendous opportunities for professional growth and advancement.
• Commitment to sustainable design.
• Solid, stable company.
• Drug-free workplace.