Company Overview

Hamilton Medical was founded with a vision: To develop intelligent ventilation solutions that make life safer for patients in critical care and easier for the people who care for them. Today, Hamilton Medical is a leading manufacturer of critical care ventilation solutions for a wide variety of patient populations, applications, and environments.

Responsibilities

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

• Analyzes production limitations and problems and facilitates root cause analysis.
• Analyzes data to bring conclusion to production and quality management.
• Reviews change orders for product releases/updates and production material and process changes.
• Conducts and documents internal non-conformance and customer complaint investigations.
• Support in Medical Device reporting (MDRs), complaints, field corrective action (Recall) and management review meeting
• Effectively engage in project as the Quality Engineering resource.
• Formulates or assists in formulating quality standards, policies, programs, plans, procedures, and practices. Assesses and approves product and process validation activities.
• Performs such individual assignments as supervisors and superiors may direct.
• Ensures adequate and continuous controls are exercised over all assigned activities affecting quality.
• Establishes and maintains effective work relationships.
• Maintains the professional competence, knowledge, and skill necessary for the satisfactory performance of all assigned responsibilities.
• Facilitates the completion of Risk Analysis documentation for new and existing products/processes.
• Organize and conduct internal supplier audits Initiates and manages Corrective/Preventative actions based on data review and input from outside sources.
• Serves as quality contact during customer and notified body audits

Qualifications

• 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.
• 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 deadline driven environment.
• Strong written and verbal communication and organizational skills

Education/Experience

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

Additional Information

• Diverse portfolio of exciting and innovative design projects
• Tremendous opportunities for professional growth and advancement
• Commitment to sustainable design
• Competitive compensation
• Excellent benefit package (medical, dental, vision insurance, paid vacation time, paid sick time, disability insurance, 401k, tuition reimbursement and much more)
• Solid stable company
• Must pass drug and background screens.
• May be required to wear Personal Protective Equipment (provided by employer).

Mid Salary