Quality Assurance Engineer

4 weeks ago


Reno, United States Hamilton Medical Full time

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).


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