Systems Quality Engineer
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We are currently recruiting for a specialist to lead process/procedure definition and maintain a continuous flow of high-quality products to our customers in a contract manufacturing environment including regulatory content for the latest and more innovative medical devices.
The successful candidate will be responsible for supporting some of our product family in both the Med tech and Industrial sectors liaising with Production, Engineering, Supply Chain and Customer contracts reporting into our Quality Manager.
Detailed Description Your day-to-day activities will include the following...
Manage performance of reports Customer liaison for quality escalations and daily quality issues ensuring measured, developed and timely responses to the customer.
Support the change management process and Customer requests as appropriate.
Create concise and accurate technical reports, communicate results and manage subsequent analysis queries Continually seek to drive improvements in product and process quality.
Create and evaluate metrics to drive the quality improvement processes.
Own, Maintain and report timely and accurate KPI's Create, and update, Procedures and Work Instructions Manage and maintain the NCMR database and report weekly to the customer.
Using appropriate statistical techniques to monitor process performance (e.g.SPC, Minitab, Ppk, Gage R & Ranalysis, sampling techniques).
Provide quality engineering support to the facility, including validation and risk management and review of technical documentation (eg.
FMEA's, control plans) Ability to design tests, evaluate results and recommend solutions to improve the processes associated with our manufacturing.
We offer a competitive total reward package: company performance bonus program, company pension and health insurance.
The opportunity to become a key member of the new product introduction team in the Health Tech Quality function driven by innovation where creativity matters.
Training and development opportunities, with us the sky is the limit
The opportunity to innovate, learn, mentor others and work toward your own vision of career success A global, collaborative culture with strong leadership imperatives to foster your growth and professional opportunities A sustainable culture where we provide opportunities for employees to give back to the community Knowledge/Skills/Competencies Strong knowledge of quality tools, ISO / QMS standards and processes (ISO 9001, ISO13485) Knowledge of data analysis and presentation software and its uses in generating reports, capturing data and presenting data in an understandable format.
Strong knowledge of product and manufacturing processes and materials properties Knowledge and understanding of the manufacturing environment and how decisions impact customer satisfaction product quality, on-time delivery and profitability of the unit Knowledge of quality tools such as FMEA, PMP, SPC, 8D methodology, etc.
Knowledge of Six sigma and Lean Kaizen.
Ability to effectively communicate with a wide variety of internal and external customers to summarize complex technical issues Knowledge of Med-tech and regulatory requirements (such as FDA and MDR) is a requirement of the role with pharma & food safety systems an advantage Ability to effectively lead and manage several projects simultaneously and coordinate multiple, changing deadlines while also working effectively on their own and in a team environment.
Ability to be an Internal Auditor Typical Education Bachelor's degree in related field 6 years or more experience in a manufacturing environment within a Quality function Experience in a Med-tech environment is essential Experience of 6 Sigma quality methods would be a distinct advantage.
Materials engineering experience/quality materials testing knowledge is an advantage Experience of leading a team is an advantage.