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Job

Quality Engineer

  • Job ref:

    11777

  • Location:

    Peabody, United States

  • Sector:

    Manufacturing Engineers

  • Contact:

    Bill Hurynowicz

  • Published:

    about 2 months ago

  • Consultant:

    Bill Hurynowicz

Summary/Objective The primary responsibilities include assisting in examination and approval of components and finished products. Utilizing different tools and techniques, the Quality Engineer will help ensure that only the highest quality products are delivered to our customers.


Essential Functions
• Conducts and supports investigations of manufacturing nonconformities; recommends, develops and implements effective corrective actions
• Coordinates, collects, analyzes and distributes quality monthly and quarterly metrics
• Participates in audits conducted by regulatory agencies and/or customers
• Participates in supplier evaluation and selection assessments
• Ensures appropriate compliance and operational effectiveness in all areas of the QMS including document control, change control, training, complaint handling, CAPA, nonconforming process and auditing (internal and external)
• Works in collaboration with Product Development to ensure that the designs, procedures and outcomes of the project are acceptable in quality.
• Proficient with Microsoft Word, Excel & PowerPoint
Competencies
• Experience with ISO 13485 certification and FDA’s 21CFR 820 preferred
• Demonstrated experience with mechanical measurements and understanding of GD&T required
• Experience in a Good Manufacturing Practice (GMP) environment is required
• Extensive experience writing and implementing policies, processes and procedures is required
• ASQ certified Quality Auditor and/or Quality Engineer is preferred but not required
• CQE, CRE, PE, CRA Certifications are highly desirable
• Lean Six Sigma Green or Black Belt required
• LIMS and ISO 17025 experience is a plus