Quality Engineer
Townsend & Associates | Devens , MA | Posted : 7/2/2014
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JOB DESCRIPTION

Responsibilities Include:

 

  • Assure all activities are in compliance with Design Controls and the relevant elements of the Quality System Regulations, with emphasis in site and corporate change control procedures for combination products and processes.
  • Assist in the establishment of a phase gated structured development process for devices and lead the quality work stream activities for product and process development initiatives.

  • Establish a complaint handling system for returned devices and conduct root cause investigations for internal and external field complaints in a timely and effective manner.

  • Assist in specification development through user studies, design of experiments (DOE’s), and analysis of data using statistical tools and in-depth evaluation of variable factors. Exercise judgment in selecting methods, techniques and evaluation criteria for obtaining results.

  • Work with cross-functional groups to assist in the development of engineering studies, design verification protocols, stability studies (for device) and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans.

  • Oversee and/or perform measurement systems analysis (MSA’s) for all critical performance test methods

  • Lead Risk Assessment activities for Application, Design, and Processes.

  • Participate in design reviews and provide expert Quality input.

  • Assist in the development and adherence to site Validation Master Plans, and execution of Operational and Performance qualifications as well as Process Validations for combination products in accordance with established regulations and approved site and corporate standards and procedures.

  • Participate in product or process improvements and optimization utilizing Lean and Six Sigma methodologies.

  • Participate in supplier, customer and/or regulatory agency audits.



JOB REQUIREMENTS

W2 ONLY!!! COPRS TO CORP.

Qualifications:

  • Bachelor of Science degree in Mechanical Engineering or relevant engineering discipline. Advanced degree a plus.

  • Minimum of 7 years of quality engineering experience in the Medical Device, Pharmaceutical or Biotechnology industry.

  • Thorough knowledge of quality systems, validation principles for product and manufacturing processes, engineering design fundamentals,

  • Thorough understanding of regulations, familiarity of regulatory environment and industry trends for combination products.

  • Working competency of statistical programs (i.e., Minitab, SAS, etc.) 

  • Certified Six Sigma Green/Black Belt or equivalent preferred Orencia Technical Remediation – Validation Workstream and Elotuzumab.

  • QA review and approval in the deliverables associated with the development and execution of remediation plans to align the abatacept drug substance process validation with current industry/regulatory expectations.

  • Facilitate sub team meetings with functional areas to assess compliance risks and track preparation activities to completion

  • QA review and approval of Manufacturing Sciences & Technology protocols and reports in support of existing abatacept drug substance manufacturing and/or future drug substance manufacturing.

  • QA review and approval of equipment qualification protocols and reports in support of existing abatacept drug substance manufacturing and/or future drug substance manufacturing.

  • Experience in review and approval of qualification/validation protocols and reports.

  • Experience in review and approval of investigations, CAPAs and change controls.

  • Extensive knowledge of US and EU cGMP regulations and guidance.

 

Desired:

  • Experience in developing and executing remediation plans for commercially validated processes.

  • Certified Quality Engineer (CQE).

  • Knowledge of biotech bulk product manufacturing and analytical testing.


JOB SNAPSHOT

Employment Type: Contractor
Base Pay: N/A
Other Pay: Competitive salary based on experience
Industry: Pharmaceutical
Biotechnology
Education: 4 Year Degree
Experience: At least 7 year(s)
Manages Others: No
Relocation: No
Required Travel: None
Job ID: 14-01012
COMPANY OVERVIEW
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Townsend & Associates, Inc.

Our Vision

Townsend & Associates, Inc. provides cutting edge staffing solutions to Fortune 500 companies. Our belief is understanding the culture and needs of our client and matching that criteria with the perfect candidate, thus establishing Townsend & Associates, Inc. as the staffing firm both clients and professionals turn to first.

Our Value

Since our inception, we have been passionate, motivated, and committed to providing the best overall experience to our clients.

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  • Quality Engineer @ Townsend & Associates