Hobson Associates

Process Development Engineer

Job Id: 21456
Job Type: Permanent
Industry: MEDICAL DEVICES
Worksite Location: Headquarters
Location: Wheeling, IL 60090
Apply Now

Manager, Quality Assurance
 

As a uniquely qualified candidate, you will:

  • Work on problems and projects of moderate to large scope where analysis of situation or data requires a review of identifiable factors.
  • Participate in decisions on scope of work at the strategic/company-wide level, selection of equipment and length of tasks.
  • Decide on scope of work at the tactical level and, when necessary, executes tactical work.
  • Provide and develop solutions to problems of moderate to company- wide scope.
  • Must be able to accomplish broad and complex assignments.
  • Provide leadership in product quality, process control, and regulatory compliance. Provide direct supervision and indirect supervision to lower-level personnel.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Leads and manages personnel responsible for the following activities or as needed, completes the activities:
    • Responsible for developing, applying, revising and maintaining quality standards for processing materials/products into partially or finished products.
    • Responsible for entire site’s quality function staff, including engineering, administration, quality systems and inspection.
    • Coordinates with Site Operations management to ensure appropriate capacity and performance of production for quality tasks.
    • Establishes quality related performance metrics for the site to ensure continuing improvement for the site.
    • Oversees, designs, and implements methods, procedures and statistically- based control plans for inspecting, testing, and evaluating the precision and accuracy of products and/or production equipment.
    • Analyzes reports and returned products and recommends corrective action.
    • Prepares documentation for inspection/testing procedures.
    • Provides competent engineering coaching in all conventional aspects of the subject matter, functional area, and assignments.
    • Plans and conducts work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria.
    • Devises new approaches to problems encountered.
    • Independently performs assignments with general instructions as to the general results expected.
    • Plans, schedules, conducts, and coordinates detailed phases of engineering work in part of a major project or in a total project of moderate scope.
    • Performs work which involves conventional engineering practice but may include a variety of complex features such as conflicting design requirements, unsuitability of conventional materials, and difficult coordination requirements.
    • Must be able to provide innovative, situation specific solutions for process control, product disposition, validation decisions and change management support.
    • Work requires a broad knowledge of precedents in the specialty area and a good knowledge of principles and practices of relates specialties.
    • Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance. Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company.
    • Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
    • Technically supervise or coordinate the work of engineers, draftspersons, technicians, and others who assist in specific assignments.
    • Ensures company safety, quality policies and procedures, actively requires conformance.
    • May require conducting internal and supplier audits. Certified as a lead auditor in ISO13485:2008 or later would be an asset.
    • May be primary escort for external audits of the facility by customers or regulatory agencies.
    • Responds to complaints from customers and investigating the root cause.
    • Knowledge of statistics and Minitab, or other advanced statistical analysis software is a must.

THE IDEAL CANDIDATE HAS...

  • BS in a related engineering discipline; and 8-10 years of related progressive experience and/or training; or MS in a related engineering discipline and 5-7 years of related progressive experience and/or training; or equivalent combination of education and experience.
  • Experience in a regulated industry required. Ability to coach and develop personnel in 6-sigma and related tools, Certified Quality Engineer (CQE) topics, or Certified Quality Manager (CQM) topics mandatory.
  • Experience in the medical device industry is a plus.
  • Certification and/or license in specific discipline would be an asset.
Contact Recruiter:

Jim Halligan

Associate - Medical Device

We’re Always
Available To You

By Phone. Online. Or In Person Want to discuss how we can serve your recruiting needs – and start achieving more of your company’s goals?

Contact Us Today