Quality Engineer

SUMMARY

The Quality Engineer is responsible for providing quality assurance knowledge and hands on support to operations to ensure that the quality system requirements are adhered to for medical device manufacturing according to but not limited ISO 13485 and FDA 820 standards.

MUST HAVE’S

  • Experience in fast paced contract manufacturing and/or manufacturing environment required
  • Experience working in a regulated environment with specific knowledge of FDA QSR and ISO 13485 standards
  • Experience in medical device manufacturing
  • Knowledge and familiarity with optical gauging product (OGP), coordinate measuring machine (CMM), other mechanical measurement equipment (indicators, micrometers, etc.), and other measuring devices used to ensure quality and acceptability of product
  • Knowledge of statistical techniques (design of experiments, measurement R&R, statistical process control)

DAILY RESPONSIBILITIES

  • Providing quality representation, support and improvements to Viant’s quality systems
  • Quality assurance testing methodology, complaint investigation and resolution, root cause analysis, corrective and preventive actions
  • Validations including but not limited to capability studies and first article inspections, internal/external audits, training initiatives, process improvement activities, and other business initiatives required quality support

EDUCATION & EXPERIENCE

  • Bachelor of Science degree in Engineering, Biology or technical field with a minimum of 3 years of experience
  • (Experience may be considered in lieu of a degree for a candidate who can demonstrate the combination of experience, training and education to be capable of successfully fulfilling all duties and responsibilities of the position.)

ADDITIONAL COMPETENCIES

  • Working knowledge of and experience with quality management software/ ERP systems
  • Computer capabilities including Minitab preferred
  • Strong interpersonal, written, and oral communication skills
  • Well organized; able to multi-task, prioritize, and manage multiple deliverables while working in a fast-pace environment
  • Problem-solving skills and critical thinking skills
  • Highly motivated, focused, self-starter
  • Quality-driven customer service
  • Able to work individually and as part of a team
  • Able to read and interpret blueprints

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ABOUT VIANT

At Viant, we focus on providing end-to-end solutions for medical device OEMs. Our deep materials expertise—combined with our experience in engineering, manufacturing, assembly, packaging, and sterilization—allows us to bring our customers’ healthcare solutions to market. We have facilities across the U.S. and around the world, including low-cost facilities in Costa Rica, China, Mexico, and Puerto Rico. Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.