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Quality Engineer in Elstree at Stryker Corporation

Date Posted: 4/14/2019

Job Snapshot

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Job Description

Your key responsibilities

  • Actively participate on custom design teams to support custom implant manufacturing.
  • Lead the risk management process for the site as required.
  • Participate in the development and improvement of the manufacturing processes for existing and new products. 
  • Work closely with key stakeholders to resolve in-house and supplier quality problems using established problem solving methodologies (Root Cause Analysis, 4D, etc). 
  • Review/approve product and process change control documentation and specifications on a divisional level as a reviewer of change control requests.
  • Provide technical expertise and support to the business
  • Review and approve regulatory standard change impact assessments.
  • Support product transfers to other plants/facilities when necessary. 
  • Review/approve nonconforming material and system documentation.
  • Participate in continuous (breakthrough) improvement activity and process re-engineering projects in support of the business
  • Achievement of strategic goals and annual operating budgets
  • Create and/or maintain SOPs, WI, and Quality forms.
  • Perform other duties as defined by QE management.

What are we looking for?

  • BS or equivalent in engineering.
  • A minimum of 1-3 years related experience in in the medical device or pharmaceutical industry
  • Working knowledge of regulatory requirements:  ISO 13485, Quality System Regulation and Medical Device Directive.
  • Working knowledge and application of quality tools such as FMEA, SPC/Process Control, Root Cause Analysis. 
  • Analytical and methodical approach to problem solving with effective communication skills at all organizational levels.
  • Ability to work with cross functional teams
  • Ability to plan and conduct meetings
  • Plan, organize, and implement multiple concurrent tasks and projects
  • Ability to negotiate internally and externally with FDA, NB and other regulatory bodies
  • Excellent analytical and writing skills
  • Effective organizational skills

Work From Home: No

Travel Percentage: None

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