Manufacturing Engineer II - new job in West Valley City, US

Manufacturing Engineer II
  • Competitive
    HOUR
  • Temporary
  • West Valley City UT, US West Valley City SALT LAKE US 84119
Job Ref: JO000134706
Sector: Engineering
Sub-sector: Engineering
Date Added: 05 January 2023


Location: West Valley City, Utah (Hybrid)

Consultant Title: Manufacturing Engineer II - Contract

Duration: 6 Months

Day to day responsibilities:

  • Generation and execution of validation plans, validation protocols (IQ/OQ/PQ), and completion reports, with a major focus on Test Method Validation and EUMDR Validation Remediation of medical devices.
  • Troubleshooting equipment/processes that do not perform as intended during validation runs.
  • Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports.
  • Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others.
  • Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions.
  • Participate in external audits such as: FDA, Notified Body (BSI) and Corporate, among others.

Qualifications:

  • Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements.
  • Knowledge in Organizational Excellence and Lean/Six Sigma.
  • Strong Project Management skills.
  • Ability to lead teams through complex projects and provide departmental technical leadership.
  • Must have excellent communication skills and a strong track record of working cross-functionally.
  • Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.

Education and/or experience:

  • BS in Engineering, preferably Mechanical, Manufacturing, Industrial, Electrical, Chemical, or Biomedical (Professional Engineer License.) or sciences related field.
  • Lean/Six Sigma Green or Black Belt Certification is a plus.

SRG ED&I and EEO Statement

• ED&I: Impellam Group and its brands are equal opportunity employers committed to diversity and inclusion.

• EEO Statement: Impellam Group is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

#IND-KW1

SRGTalent https://www.srgtalent.com https://www.srgtalent.com/-/media/srg/1---new-website/logos/srg-impellam-lock-up-logo---large.png
02/02/2023 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Kristen Wojtkowiak

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