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Quality Controller in Elstree at Stryker Corporation

Date Posted: 3/6/2019

Job Snapshot

Job Description

Under general supervision, the Quality Inspector will perform inspection and testing activities of product in the incoming receipt, manufacture, packaging and /or release of Medical Devices at Stryker, ensuring product quality and throughput goals are met. Ensure compliance to procedures and practices, at all times.

Working within the Inspection Team, is responsible for inspection related activities, specific to each sites’ requirements, may include but not limited to the following,

  • Perform dimensional and/or visual inspection to blueprint using  gauges and other reliant inspection equipment
  • Perform material and component inspections.
  • Assess inspection methodology and initiate changes to improve processes and/or procedures.
  • Assist in improvement projects to optimize inspection processes.
  • Perform First Article Inspection (FAI) and verify FAI data (incl. statistical analysis) is acceptable.
  • Read and inspect to blueprints and/or inspection guide sheets / instructions
  • Perform Document Review, analyse, inspect and archive DHRs (paper-based and/or electronically) in compliance to GMP/GDP requirements prior to release to finished goods.
  • Perform computer system transactions related to router inspections, etc.
  • Segregate quarantine and complete documentation for non-conforming materials when necessary.
  • Initiation and ownership of quarantine tickets (non-conformance reports)
  • Assist in Quality investigations, provides input to correction resolution, rework, problem solving of issues, and process improvements, across multiple areas
  • Perform product release disposition tasks in the ERP system
  • Support and report on the achievement of Inspection Team KPI's
  • Responsible for management and control of quarantined material.
  • Support supplier investigations related to Quality issues
  • Assist and support in the documentation, specification, standard form or Inspection Guide Sheet development process.
  • Provide on the job support and guidance to other Inspectors as needed in accordance with any changes in product, process or cell staffing.
  • Leaving Certificate /High School/Realschule Diploma or equivalent.
  • Vocational/technical school training/certificate (Berufsausbildung) an advantage.
  • Formal GD&T training (Geometric Dimensioning and Tolerancing) preferred.
  • 5+ years of product inspection experience in an ISO 13485 / cGMP manufacturing environment.
  • Experience in site specific specialised processes and technology preferable.
  • Sustained performance in an ISO 13485 / cGMP manufacturing environment.
  • Demonstrated performance in both quality and productivity.
  • Demonstrated expertise in inspection methods/processes, e.g.  CMM and/or OGP operation.
  • Demonstrated ability to assist and support in the development process for document specifications and Inspection Guide Sheets.
  • Demonstrated ability to read and interpret complex blueprints
  • Demonstrated proficiency with Inspection Sampling Plans
  • Demonstrated expertise in the use of all standard inspection tools including calipers, micrometers, height gages and comparators
  • Demonstrated proficiency in Geometric Dimensioning and Tolerancing (GD&T)
  • Demonstrated communication and interpersonal skills and the ability to work in a team-based environment that heavily emphasized quality, performance, cross-training, customer service and accountability
  • Demonstarted strong initiative and contribution in correction resolution, and problem solving of issues
  • Excellent attention to detail.
  • Strong understanding of mathematical concepts

Work From Home: No

Travel Percentage: None

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