• Senior Quality Engineer

    Job Locations US-PA-State College
    Job Post Information* : Posted Date 3 months ago(2/28/2018 10:48 AM)
    # of Openings
    Regular Full-Time
  • Overview

    The Sr. Quality Engineer develops and administers quality and assurance programs/systems under the direction of the Quality Manager.  Interacts with manufacturing, engineering, and other managers to direct the efforts of quality assurance in implementing quality assurance programs.  Drives continuous improvement of process and product quality and performance and aligns local systems with corporate quality management systems.


    • Supplier Quality
      • Establish quality requirements and quality plans for supplier; conducting supplier audits.
      • Support purchasing in selecting and monitoring suppliers.  Experience with product transfer and requalification desired.
      • Provide QA reports on STI’s external suppliers.  Interface with supplier quality representatives concerning problems with quality assurance and assure that effective corrective action is implemented. 


    • QA Representative for Change Control
      • Assist with establishing, implementing, and maintaining the QMS to cGMP requirements
      • Review customer purchase orders, contracts, and change request to ensure that the necessary criteria and provisions are included in the quality and process plans. 
      • On-site training for QMS procedures.  Need to be able to design training program with feedback loops that ensure site understanding on quality standards and activities.


    • Product and Manufacturing Support
      • Attend daily Manufacturing “Stand Up” meetings and provide support.
      • Support manufacturing engineering in process control, process validations, process improvement, process training programs, software control and validations, risk management. 
      • Develop, apply, and maintain quality requirements and standards for manufactured products.
      • Design, install, and evaluate quality processes, sampling systems using statistical techniques, inspection processes, test methodologies, and quality plans.  Ability to prepare reports with data showing effectiveness of these systems is critical.
      • Serve as the meeting facilitator for the Materials Review Board (MRB) and providing direction and support to Incoming Inspection personnel. Improve Incoming Inspection system/capabilities.


    • A Bachelor’s Degree in an Engineering discipline and minimum of 3-5 years’ experience in a regulated environment.  Knowledge of ISO and GMP a plus.
    • Demonstrated attention to detail and problem solving skills.  Must be able to work in a participative, team oriented environment. 
    • Excellent written communication and interpersonal skills along with strong time management and organizational skills
    • Provide formal and informal leadership to individuals and teams
    • Excellent computer skills (including, but not limited to: Windows, MS office, ERP systems).
    • Demonstrated ability to develop and implement systems and processes in a fast-paced manufacturing environment
    • Ability to travel up to but no more than 20% of the time
    • Customer oriented towards both internal and external customers


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