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Quality Engineer

Description

Reporting to the Site Quality Assurance Lead, the main focus of the role is primarily to ensure the quality standards are met. In this role you will form part of a cross functional team involved in Assembly. You will be working in both manufacturing (assembly) & non-manufacturing (QMS process based) setting. You will also have authority for 3 Quality Inspectors, by completing probation reviews, performance reviews and providing direct coaching and support.

What You Will Do In Your Role

  • Motivate staff by promoting a positive environment where achievements and accountabilities are acknowledged and open two-way communication encouraged.
  • Provide input from a quality perspective to product & process risk assessments, pFMEA.
  • Perform and provide support to validations, metrology, document control, internal auditing.
  • Interact directly with vendors and customers.
  • Liaise with other departments as required as part of day-to-day activities.
  • Perform process control monitoring & improvement activities.
  • Work & report on CAPA, vendor CAPA, MRB, customer complaint activities.
  • Support all steps of the change control and NPI processes, mainly: initial quality assessment, vendor selection assessment and qualification and validation requirements.
  • Take part in Pilot Production & Product Approval, as well as reviews of Quality & Regulatory requirements.

The Experience You Will Bring

Requirements:

  • Bachelor's degree or equivalent in Quality, Engineering, Science or related discipline with past working experience in this area. 
  • Knowledge of ISO 13485 or ISO 9001.
  • Auditor's experience: internal or external or customer's audits. 
  • Responsibility for successfully accomplishing work objectives and delivering business results; ability of setting high standards of performance for self and others.
  • Able to find opportunities to improve and extend contribution to the organization.
  • Ability to demonstrate the highest commitment to integrity and showing respect for and value all individuals for their diverse backgrounds, experiences, styles, approaches and ideas. 
  • Strong organizational skills: ability to define, delineate roles and responsibilities effectively, plan well, facilitate change, optimize quality and productivity.


What Will Put You Ahead

  • Previous experience preferably in a medical device manufacturing environment.
  • Knowledge of ISO 14971.
  • Experience with ERP systems, preferably SAP. 

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