Manufacturing Engineer II - Investigations

1970-01-01Davis Companieshttp://www.daviscos.com/wp-content/themes/davis_theme/assets/images/logo.svg325 Donald J. Lynch Boulevard, Suite 201MarlboroughMA01752USAcustomer support[+800-482-9494][+508-481-8519]
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Manufacturing Engineer II - Investigations

  • Specialty:

    Engineering
    • City:

      Bedford
    • State:

      MA
    • 01730
  • Assignment Type:

    Direct Hire
  • Job Id:

    44597
  • Payrate:

    $48.08

Description

Manufacturing Engineer II

The Manufacturing Engineer II will support diverse commercial and new product development projects for medical device and pharmaceutical products.

Responsibilities:

  • Change control ownership, leading C&Q activities, root cause investigations, and corrective actions 
  • Operations lead for Quality Events and Material Review Board meetings
  • Lead cross-functional teams for manufacturing trending and continuous process improvements
  • Generate, review and approve internal operating procedures and specifications
  • Assist with continued company certification to the appropriate Quality System Standards and Regulations, and assist with all related inspections as required
  • Assist in the development and implementation of manufacturing processes for complex product development projects for medical device and/or pharmaceutical products

Qualifications:

  • BS in Engineering, preferably Chemical or Mechanical
  • Minimum of 4 years’ experience in manufacturing or product development in the pharmaceutical or device industries
  • Proven experience leading investigations is a must
  • Six Sigma qualification preferred
  • Familiar with ISO 9000/ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations
  • Experience with statistical analysis of data
  • Must be able to work in both cleanroom and chemical laboratory environments

#MON

Quick Apply

  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
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  • By applying to this position and providing my contact information, I give The DAVIS Companies permission to provide me with email communications and information.

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