NPI/Quality Engineer - County Waterford
We are seeking a highly motivated and experienced NPI/Quality Engineer to join our team in County Waterford.
This role will involve assisting in the development and implementation of quality plans, programs, and procedures using quality control statistics, lean manufacturing concepts, and analyses. The successful candidate will ensure that performance and product quality conform to established company, customer, and regulatory requirements.
Key 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 specialized 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. Coordinate 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 utilizing 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.
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 organization, communication, computer, and presentation skills.
* Excellent initiative, decision-making, and ability to work in a core team environment.
* Excellent time management skills.
* Solution-driven with emphasis on performance and results.