Quality Engineer

Ametek, Inc.•Bridgeport, CT

About The Position

Responsible to support the manufacture of surgical instruments, responsible for translating customer requirements into effective inspection criteria to be deployed by machine operators for the assurance of quality and delivering zero defects to the next process and customer.

Requirements

  • 4 Year / Bachelor Degree in Engineering or related field
  • 3- 6 years experience with tight tolerance measurement systems in machining applications
  • Blueprint reading
  • GD&T
  • Working knowledge of short-run process control methods
  • DOE
  • ISO standards
  • FDA quality system regulations
  • Working knowledge of statistical analysis and methods
  • Minimum 3-5 years' experience in quality
  • Previous experience with CMM, optical measuring equipment, and metrology applied in machining applications
  • Proficiency in blueprint reading and GD&T to include principles of quality engineering
  • Excellent interpersonal, scheduling, leadership, and technical quality skills
  • A strong work ethic with the ability to cultivate and maintain cooperation from others
  • Ability to work with minimal supervision and actively participate in a team-oriented manufacturing environment
  • Proficient in use of various test equipment such as optical comparators, micrometers, calipers, gage blocks, pin gages, etc.
  • Be able to meet the visual acuity requirements (shades of color and color blindness).

Nice To Haves

  • Supervisory or leadership experience strongly preferred
  • CQT strongly preferred
  • CQI a plus

Responsibilities

  • Ensuring cell processes are correctly base lined & controlled, accounting for known variability through selection & frequency of inspection, sampling plans, or implementation of SPC.
  • Developing and implementing inspection/validation techniques to verify products meet requirements at the earliest point in the production process.
  • Specifying the need for new inspection equipment and instructing others in its proper use.
  • Obtaining technical counsel from Quality Manager to fully understand and interpret customer requirements so that the most accurate inspection methods and metrology are deployed.
  • Demonstrating technical leadership in support of Quality Inspectors.
  • Auditing and continuously improving operator quality in the pursuit of zero defects.
  • Performing and assisting in developing corrective action responses for internal and external customers.
  • Investigating deviations, OOS, complaints, returns, recalls, and field-alerts.
  • Supporting the Material Review Board (MRB) for internal non-conformances and customer returns.
  • Implementing, monitoring, and tracking progress of First Article Samples.
  • Working with the Quality team to ensure PVE type deliverables are completed per customer requirements.
  • Creating and supporting ECNs and SCRs (product).
  • Providing new hire and on-going training to ensure requirements are met and enable cell quality technicians to increase their knowledge and skills.
  • Performing inspection duties as required, including day-to-day oversight of quality such as batch testing, inspection, calibration, environmental monitoring, qualification, and document review.
  • Interfacing with customers and suppliers at a professional level.
  • Supporting quality improvement and cost savings initiatives.
  • Supporting both internal and external audits of all corporate quality systems and demonstrating compliance through objective evidence.
  • Supervising employees, as needed.
  • Assisting in receiving and conducting receiving inspections on products from outside resources.
  • Assisting the Sr Quality Engineer and/or Manager with other tasks, as assigned.
  • Leading or assisting in multi-function continuous improvement activities as requested by the Quality Manager, including Gage R&R studies, training others in statistical techniques, and process control/validations.
  • Training others in similar roles once competency in the position is demonstrated.
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