Modis has a Quality Engineer III opportunity available in Boston, MA. This is a direct hire opportunity. The salary range is between $110,000 and $120,000 per year.
Quality Engineer III responsibilities include:
• Technical support for and final review and approval of customer complaint investigation, support new product development and support validations for new and existing products, processes and equipment.
• Establish and maintain Quality Management System procedures. Facilitate the execution of Risk Management activities.
• Identify statistically based sampling plans for inspections and validations. Collection and reporting of metrics and data as required
• Ensure compliance with cGMP, QSR, ISO13485, MDD, and other applicable regulations/standards
• Participate in FDA inspections, ISO Certification and surveillance audits and customer audits
• Identify and implement opportunities for continuous improvement.
• Interact and coordinate activities with other departments, external vendors and customers
• Assist or lead in the identification and implementation of CAPA
• Aid in the implementation SPC control system with Manufacturing and Quality Control
• Completes internal quality system audits. Provides support necessary for supplier controls, including but not limited to supplier audits
• Participates in Post-Market Surveillance (PMS) activities as required
• BS degree in Engineering, Science (Biology, Chemistry, Physics, etc.), or Math (Statistics)
• Minimum of three years’ experience in Engineering, working in regulated industry (Medical Device, Pharma, Aerospace)
• Knowledge of statistical sampling and analysis
• Familiar with the MS Office Suite, including Microsoft Visio and Project
• Knowledge of quality system standards, and other national and international regulations and standards
• Good organizational, writing and verbal communication skills
• Must be able to read and write in English. Must be able to demonstrate comprehension of written English by successfully completing unassisted written tests, including, but not limited to, Work Instructions and Standard Operating Procedures.
If you are interested in this Quality Engineer III opportunity in Boston, MA) then please click APPLY NOW.
Equal Opportunity Employer/Veterans/Disabled
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The Company will consider qualified applicants with arrest and conviction records.