Job Detail: Manufacturing Documentation Engineer

Job Order #11845
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Post Date Job Tile Location Category
9/3/2021 Manufacturing Documentation Engineer Houston - Texas Biotech

Description:


Walker Elliott is working on an outstanding role for a Manufacturing Documentation Engineer who will be responsible for reviewing the department's engineering designs, manufactured products, and technical reporting to regulatory entities and make the necessary recommendations and engineering/technical changes as required.

ESSENTIAL FUNCTIONS PERFORMED

  • Performs routine technical work requiring applying standard techniques, procedures, and criteria in carrying out engineering tasks.
  • Uses limited amounts of discretionary judgment in making decisions regarding technical alternatives.
  • Performs work of some higher technical level for training purposes, and work is screened to ensure the correct application of scientific principles.
  • Coordinates and prepares document packages for:
    • Regulatory submissions (domestic and international)
    • Legalization of regulatory documentation for international submissions
    • Governmental Inspection
    • Recalls
    • Company policies and procedures
  • Interacts, as directed, with various levels of management, external agencies, and companies.
  • Participates on project task teams.
  • Works on special projects by writing ECN’s and creating prototypes under general direction.
  • Performs other related duties and tasks as required.

QUALIFICATIONS

  • BS in Engineering or technical field related to the department of assignment or industry. Master's Degrees are preferred.
  • Understand Engineering Changes and write the documentation for the engineering department personnel and regulatory agencies.
  • Able to analyze regulatory requirements and use analytical skills to make recommendations to the department's engineering personnel, manufacturing area, and research departments.
  • Competent using PC. Knowledge of MS Excel spreadsheets, MS Word, and other technical databases and other applicable software programs.
  • Must have strong interpersonal and organizational skills and the ability to work effectively as a team member.
  • Able to understand and/or know U.S. and international standards for medical devices or related products.
  • Understanding of IQ, OQ and PQ: installation qualification, operational qualification, and performance qualification, respectively.

COMPETENCIES

  • Standard scientific techniques/procedures/criteria
  • Special projects/ECN
  • IQ, OQ, and PQ.

Do not apply unless you are authorized to work in the United States for any employer as client company cannot sponsor or transfer visas at this time.

Walker Elliott is an Equal Opportunity Employer.

For additional information, please email your resume to resumes@walker-elliott.com or apply online.


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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or national origin.


 

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Walker Elliott

10777 Westheimer, Suite 220
Houston, TX 77042
Phone: 713-482-3750

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