Sr Engineer, Quality

This is where your work makes a difference.

The Senior Quality Engineer provides engineering support to the plant through process optimization, risk management, validation, defect prevention, project management, and technical evaluations. This role ensures compliance with GMP/QSRs and all applicable standards related to product/process validation. This role may lead project-based individual contributors/contractors or mentor newer Quality Engineers as needed.

• Leads or assists in developing and implementing new machines/processes/computer systems and in improvements to existing methods. Requirements for new/improved machines/processes/computer systems, including system requirements/design specification, risk analysis, installation qualification, operational qualifications, and performance qualification are all in the scope of the Quality Engineer. This requires interfacing with local Quality, Production, and Engineering as well as Corporate Engineering, Quality, and Regulatory functions.
• Supports the manufacturing plant through implementation of process improvements.
• Conducts process/financial analysis through conventional methods of ROI, quality trending/tools, MIP measurements and implements/drives improvements.
• Manages small projects (both new and improvement) to include cost, change management, implementation, and validation. Leads cross-functional teams.
• Leads ongoing validation and verification programs such as Continuous Process Verification (CPV), Validation Master Plans, Periodic Reviews, Computer Systems Validation, Stability program and Calibration.
• Performs statistical analysis to support Quality and Production.
• Evaluates sampling/testing/qualification plans with respect to current quality levels and test methods.
• Accountable for the testing required in conjunction with protocols, in-process risk assessment, and situation appraisal.
• Composes protocols, final reports, studies, experiments and general information reports for use by management. Routes documents in the Document Management System.
• Leads/coordinates validation efforts of new equipment and changes to existing equipment.
• Assists in evaluation of customer complaints, risk management and technical summaries.
• Assists in evaluation of supplier product/process changes.
• Assures compliance of manufacturing and quality control operations with respect to corporate specifications, SOP’s, Good Manufacturing Practices/Quality System Regulations (FDA 21
  
  CFR ), Corporate Quality Manual (CQM), ISO , and other applicable standards and regulations.
• Implements a basic knowledge of engineering, statistical/six sigma tools and associated methods into the analysis of processes for identification of potential opportunities of improvement.
• Supports, reviews and approves, and may own execution of CAPA investigation using DMAIC process and technical writing skills.
• Exhibits excellent technical writing skills, especially as it relates to the CAPA/Complaint process and the actions associated with those activities.
• Understands and knows various international standards relating to a variety of topics, as needed (i.e. ASTM, ASRAE, ANSI, AAMI, ISO standards applicable to scope of work).
• Responsible for:
  • Initiating action to prevent the occurrence of any nonconformities relating to product, process, and quality system.
  • Identifying problems relating to the product, process and quality system.
  • Initiating and implementing solutions through designated channels.
  • Establishing controls on a process and establishing verification/monitoring of such.
  • Driving improvements into the production process, from conception to sustainable production methods.
  • Maintaining a safe work environment for self and others at all times.

• Strong technical writing, investigation and communication skills required.
• Experience leading cross-functional teams preferred.
• Computer proficiency in Microsoft Word, Excel, Outlook and the ability to use enterprise software (examples include: JDE, BPLM, POMs, Maximo, etc.) Familiarity with MINITAB preferred.
• Minimum 3 years of experience in regulated manufacturing environment.
• BS degree required, preferably in Engineering,…