Quality Assurance Engineer
Location
Reno, NV | United States
Job description
Hamilton Company is a worldwide leader in the design and manufacture of manual, semi-automated and robotic products for precision fluid measuring. We specialize in the development, manufacturing and customization of precision measurement devices, automated liquid handling stations, and sample management systems. For more than 60 years, Hamilton has been satisfying customer needs by combining quality materials with skilled workmanship, ensuring the highest level of performance of every precision fluid measuring device we manufacture.
The Quality Assurance Specialist ensures compliance to existing procedures and regulations through document review audits, 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
- Ability to read and understand engineering design drawings, technical plans, and reports.
- 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
- Bachelor's Degree in engineering or a scientific discipline required .
- Minimum of 3 years of quality assurance experience required .
- Certification in Quality (CQE CSSBB CQA) preferred.
- Anticipated salary range is $60,000 - $110,000/year based on experience.
- Diverse portfolio of exciting and innovative design projects.
- Tremendous opportunities for professional growth.
- Commitment to sustainable design.
- Competitive compensation.
- Excellent benefit package includes medical, dental, vision insurance, paid vacation time, paid sick time, disability insurance, 401k, tuition reimbursement and more.
- Solid stable company.
- Must pass drug and background screens.
- May be required to wear Personal Protective Equipment (provided by employer).
USD $85,000.00/Yr.
Job tags
Salary