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Quality Engineer

Katalyst Healthcares & Life Sciences Manville, NJ
  • Expired: 17 days ago. Applications are no longer accepted.
  • The Quality Engineer executes the principles of product and service quality evaluation and control for the ETS enterprise.
  • Key responsibilities include development and operation of quality control systems.
  • Application and analysis of testing and inspection procedures.
  • The ability to use metrology and statistical methods to diagnose and correct improper quality control practices.
  • An understanding of human factors and motivation, facility with quality cost concepts and techniques.
  • the knowledge and ability to develop and administer management information systems and to audit quality systems for deficiency identification and correction.
Roles and Responsibilities:
  • Serve as key user of the Office of Quality Audit Module and Process Conformance Review for the Enterprise
  • Serve as a primary resource for planning, executing, and follow-up for Process Conformance reviews and verifications for ETS Enterprise wide
  • Provide methodical and independent assessment of business processes and their effectiveness in the enterprise
  • Provide recommendations and advice for continual improvement of the enterprise CAPA/Audit Software modules
  • Play a key role in coordinating the Office of Quality leadership in the Quality Management System aspects of Supplier Management
  • Cooperate with suppliers to ensure ETS standards are effectively communicated and controlled
  • Assist Process Owners in problem analysis and presentation of results, ensuring Client concerns and questions are effectively addressed
  • Use standard Process Management tools (e.g. Process Profiles, Process Maps, RACI charts)
  • Use proven problem solving tools and techniques (e.g. Six Sigma) as needed for analysis and improvement
  • Work cross-functionally to gain agreement on process boundaries, metrics, control limits, and scope of investigation
  • Ensure that customer input and feedback is highly visible to process and sub-process owners.
  • Recommend and design appropriate process and metrics modifications.
  • Work with Business Process Consultants to assure alignment of Client requirements with key ETS processes and to share methods and best practices.
  • Gather objective evidence and data to describe the effectiveness of processes and changes to those processes.
  • Provide trending information from data available on a regular interval to indicate areas of risk to the organization.
  • Take the initiative to remain current in the field and to share new knowledge and approaches with colleagues.
  • This includes communication and promulgation of suppliers' best practices throughout the organization.
  • Leads various special projects as requested or approved by Executive Director.
Education and Experience:
  • Education, Certifications, or Special Licenses.
  • Bachelor's degree in relevant discipline is required.
  • Process improvement experience: Six Sigma, Lean Manufacturing or comparable certification.
  • ASQ Certification as CMQ/OE or QE or equivalent relevant certification (with current certificate evidence preferred).
  • Minimum 5 years of progressively responsible experience as a quality, process, manufacturing, or industrial engineer.
  • Other Requirements (Specialized skill sets, behavioral/technical)
  • Demonstrated work experience as a process-based trained Lead internal auditor (with certificate evidence preferred).
  • Expertise in Quality Management Systems Internal Auditing with ISO 9000-2000 or 2008 or equivalent ISO/TS 16949-2002 or 2009 series.
  • Expertise in the use and application the Certified Quality Engineering or Six-Sigma tools.
  • Ability to analyze complex processes and communicate findings clearly and concisely.
  • Proven ability to work with or lead cross-functional teams, encouraging teamwork and shared success.
  • Firm grasp of Quality Management System principles.

Katalyst Healthcares & Life Sciences


Manville, NJ
08835 USA