Manufacturing Quality Engineer

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Manufacturing Quality Engineer

  • Specialty:

    Engineering
  • Title:

    Manufacturing Quality Engineer
    • City:

      Boxborough
    • State:

      MA
    • Zip Code:

      01719
  • Start date:

    04-15-2020
  • Status:

    Closed
  • Assignment Type:

    Direct Hire
  • Job Id:

    52946

Description

 

Position Description

 

Position Title:

Manufacturing Quality Engineer

Department:

Operations

Reports to:

Quality Manager

Direct Reports:

None

Location:

Boxborough, MA

Position Type:

Full time

Date:

Jan 2020

 

POSITION SUMMARY:

 This role is high-impact, with significant visibility within the organization, and the opportunity to provide personal influence towards a growing area of the client; In-Vitro Diagnostic Device manufacturing. The Manufacturing Quality Engineer supports production/project activities and quality objectives, provides guidance to the Engineering, Production, and Project Manager teams, and has influence extending from the client's supply chain through to the end customer.

 

Required Skills/Experience: 

  • Demonstrated knowledge of manufacturing, engineering, and quality tools and techniques, including: IQ/OQ/PQ, Design for Manufacturability (DfM), GD&T, IQ/OQ/PQ, GR&R, cGMP.
  • Experience working with Medical Device or IVD production under ISO 13485:2016 and FDA QSR compliant Quality Systems
  • Kaizen and/or Lean Manufacturing experience
  • Familiarity with dimensional inspection methods using hand tools, calipers, force gauges, CMM, etc
  • Microsoft Office tools

 

KEY RESPONSIBILITIES:

Owning and executing the following:

  • Manufacturing process development/improvement
  • Equipment Qualification (IQ, OQ, PQ), Validation support
  • Root Cause Investigation and development of corrective/preventive action strategies
  • Provide technical support and guidance to production associates.
  • Ensuring process compliance to ISO 13485:2016 and ISO 9001:2015 standards
  • Clearly and effectively communicating with our customers

 

Critical Success Factors

  • Highly motivated, and comfortable in a fast-paced team environment
  • Demonstrated ability to lead and influence others with a quality and customer-first mentality through superior communication skills.
  • Hands-on in their approach, actively engaging the production floor.

 

 

Education:

  • BS in Mechanical or Industrial Engineering, or related technical field

 

TRAVEL:  <10 % of overnight travel required for the position.

 

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