Job Description
NPI/Quality Engineer
CORE DUTIES AND RESPONSIBILITIES:
* Develop and maintain QA plans and process routings, which reflect intended/actual activities.
* Provide support for all quoting activities by participation in initial process design, development, and implementation phases.
* Evaluate and support inspection processes via inspection aids and instruction guidelines.
* Support all training programs by development and implementation of specialised training sessions for all applicable functions.
* Conduct periodic review and maintenance of all documentation files; develop appropriate systems for document storage and access.
* Review all supplier or customer discrepancies. Co-ordinate and track the corrective/preventative action effort.
* Provide trend analysis of defects occurring at the customer, supplier and internally.
* Participate in vendor survey activities as applicable.
* Drive proactive participation with suppliers and (when possible) aid in their process improvement efforts.
* Interface with all departments as applied to the Policies and Procedures with special regard to ISO, EN4600 and GMP documentation.
* Monitor departmental activities and provide technical and logistical guidance/support for the quality engineering staff as applicable.
* Interface and provide technical support on quality issues with the customer as needed.
* Support and focus corrective action efforts utilising the SPC data and corrective action tracking package, and create and implement any meetings, procedures, or team-building concepts as necessary as part of the corrective/preventative effort.
* Serve as liaison with suppliers or customers on quality related issues.
* Improve technical support for the quality organisation.
Requirements:
* Bachelor's degree
* At least 2 years' relevant experience, or equivalent combination of education and experience, in Medical Device and/or Pharma industry.
* Preferably with knowledge/experience of manufacturing engineering, exposure to high volume medical device or pharma automated assembly lines.
* Excellent organisation, communication, computer & presentation skills.
* Excellent initiative, decision making and be able to work in a core team environment.
* Excellent time management skills.
* Solution driven with emphasis on performance and results.