Connexion Systems & Engineering, a Boston based IT and Engineering Solutions Company immediately seeks individuals with the following skills:
The Quality/Validation Engineer will be a critical contributor in a mission that truly represents an once-in-a-lifetime opportunity to join a company that is making significant investments in establishing US manufacturing, expanding internationally, and delivering a consistent cadence of product innovations to the market and investing in its people.
The successful candidate will be responsible for providing Quality Engineering support to Global Engineering while performing acceptance testing, IQ, OQ and Test Method Validation. This effort is critical to ensure new automation delivers the highest quality product to the customer. It requires creativity and foresight to work with other functions to ensure compliance and the accomplishment of the goal for shipping new equipment from our supplier to our manufacturing site. The position requires working alongside engineering, quality, manufacturing and key suppliers to support the validation of new equipment.
Performs and documents Root Cause investigations related to product and components rejections. Formulate corrective and preventive actions; implements those actions in order to improve quality levels and regulatory compliance.
• Provide validation support by applying manufacturing quality tools including, but not limited to: FMEA, DFMEA, PFMEA, IQ, OQ, PQ, control plans, process verification/validation plans, Cpk, Cp, SPC, DOE, process data analysis, and DMAIC.
• Write and review protocols and reports of Process and Test Method Validations. Design, complete protocols and write reports for gauge R&R analysis.
• Write and review quality documentation such as procedures, test protocols and reports.
• Prepare reports by collecting, analyzing, and summarizing data. Analyze data and make decisions using valid statistical techniques.
• Establish statistical confidence by identifying sample size and acceptable error; determine levels of confidence.
• Support Global Engineering by resolving process and material related quality problems with future automation.
• Assist in equipment process monitoring and quality measurement tools.
• Expected to be able to manage validation projects with little direction from Global Engineering leads.
• Apply SPC methods for analyzing data to evaluate the current process and process changes.
• Track and prepare reports related to equipment verification and validation.
• Presents quality data to Global Engineering leads.
• Perform other duties as assigned.
Education and Experience:
• BS degree in engineering, a technical or scientific discipline.
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Duration: Long Term Contract
Locations: Billerica, MA
ConneXion Systems & Engineering
490 Boston Post Road
Sudbury, MA 01776