Quality & Reliability Engineer

  • 0 yrs
  • Not Disclosed

Job Description

Job Overview< b> < p> < p>

The Senior Quality Engineer investigates the root cause and follows through on effective corrective actions to prevent reoccurrence for the customer and internal quality issues. This person will establish inspection standards, plans, frequencies and test methods as well as establish and maintain FMEA’s. Responsibilities include: < p>

  • Preparing and updating Operations procedures and associated documentation.Reporting area of responsibility metrics.< li>
  • Supporting customer and surveillance accreditation audits.< li>
  • The Senior Quality Engineer will perform an active role in quality planning and new product introduction from a quality perspective.< li>
  • Maintain relevant documentation to comply with quality standards and customer requirements.< li>
  • Quality review of responsible area validation documentation.< li>
  • Performing an active role in further development and continuous improvement of the quality management system.< li>
  • Will assist in issues related to Metrology, Inspection, Testing, Product stability, and vendor certification programs.< li>
  • Will lead and manage the Material Board to ensure products are appropriately dispositioned within time requirements.< li>
  • Participates as a key member of new product development core teams, to help ensure that new product quality plans (validation plans, raw component material specifications, etc.) and risk management files are appropriately established.< li>
  • Will assist and train associates in concepts of probability and statistics.< li>
  • Design and develop forms and instructions for recording, evaluating, and reporting quality data.< li>
  • Investigate and implement corrective and preventive actions (CAPAs) to meet business and compliance requirements.< li>
  • Work with suppliers of both raw materials and components, to improve product quality and or resolve quality issues.< li>
  • Perform Supplier Quality Audits as necessary.< li>
  • Assist with the development and maintenance of the company wide validation programs.< li>
  • Reports verbally and in writing to the Director Manager regarding the progress and results of projects.< li>
  • Participates with the Director Manager in the preparation of divisional, departmental, and project goals.< li>
  • Assists the Director Manager in presentations of technical nature when requested.< li>
  • Ensure that every product and service we supply conforms to FDA and Quality System Regulations as well as EN46001 ISO13485 MDD Standards.< li>

    What your background should look like:< b> < b> < p> < p>

  • Min. 5 years' experience as quality engineer in a similar position and industry< li>
  • 5+ years of quality experience in component and device manufacturing< li>
  • 3+ years experience with Medical Devices < li>
  • ASQ Certified Quality Engineer preferred< li>
  • Good working knowledge of ISO FDA MDD and other Product Development related regulatory requirements< li>
  • Six Sigma Green Black belt preferred < li>
  • BS BA degree with a scientific emphasis required < li>

    Competencies< b> < b> < p> < p> Values: Integrity, Accountability,Teamwork, Innovation