Sr. Quality Engineer

Ormco-posted about 1 month ago
Full-time • Mid Level
Pomona, CA
5,001-10,000 employees
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The Sr. Quality Engineer plans and conducts activities concerned with the quality assurance of industrial processes, materials, and products. The Sr. Quality Engineer will be responsible for ensuring the highest quality standards in our products and processes, working closely with cross-functional teams to develop, implement, and maintain quality assurance protocols that comply with regulatory requirements an industry standard. The Sr. Quality Engineer will possess a deep understanding of quality management systems, regulatory requirements, and risk management principles. The Sr. Quality Engineer will report directly to the Quality Engineering Manager.

  • Actively participates in defining customer requirement, product claims and target markets early in the product development lifecycle.
  • Performs quality engineering reviews of design documentation for compliance with stated requirements.
  • Lead complex technical problems where analysis of situations or data requires an in-depth evaluation of various factors and solve a wide range of difficult problems in creative and effective ways.
  • Develops or participates in establishing requirements for all verification and validation (design and process) activities.
  • Apply state-of-the-art inspection and quality engineering/assurance techniques, procedures, instruments, equipment, theories, principles and concepts to products and processes.
  • Leads development of Risk Management documentation.
  • Leads/participates in data collection, analysis, trending and reporting on non-conformances and investigations to determine root cause, corrective and preventive actions.
  • Mentors junior Quality Engineers as required.
  • Participates in internal and external audits and inspections.
  • Maintains process and software validation plans.
  • Writes validation protocols.
  • Facilitates completion of validation activities, performs data analysis, and writes the validation report.
  • Prepares reports to communicate involvement and results of quality assurance and quality engineering activities.
  • Prepares and presents technical and program information to team members and management.
  • Directs technical and administrative workers engaged in quality assurance activities.
  • Applies statistical analysis of data to evaluate the current process and process changes.
  • Maintains a working knowledge of FDA GMP, ISO 13485 standards and other applicable standards.
  • Documents data obtained during all quality assurance activities, consistent with company policies and procedures.
  • Prepares reports to communicate involvement and results of quality assurance and quality engineering activities.
  • Reviews all purchased products or components and provides input to the decision of whether to accept the product and future purchases from the vendor.
  • Supports Regulatory Affairs with their activities related to submissions and notified body filings.
  • Develop an understanding of Envista Business System (EBS) processes and tools and utilize in the execution of projects (i.e. Problem-Solving Process (PSP) and Visual Project Management (VPM)).
  • Any duties or tasks assigned by Supervisor/Manager.
  • Bachelor's degree (B. S.) in Engineering or a related field.
  • 5 years of experience in quality engineering within medical device industry.
  • FDA Quality System Regulation Part 820 and ISO 13485 experience.
  • Effective interpersonal communication skills and able to interface with cross functional teams.
  • Possess critical thinking skills and able to be assertive & challenge the process in a diplomatic manner.
  • Strong verbal, written, and interpersonal skills (explains difficult or sensitive information; works to build consensus); able to explain technical terminology in layman's terms to product development groups, peers, and senior management.
  • Highly organized with a detail-oriented mindset
  • Portray flexibility and multi-tasking in a dynamic environment with changing priorities.
  • Adaptable to work with software-based development and automated processes.
  • Communicates significant issues or developments identified during quality assurance activities and provides recommended process improvements to management.
  • Works well in a cross-functional team; will speak up to provide guidance to other team members.
  • Solves complex problems; takes a new perspective on existing solutions; exercises judgement based on the analysis of multiple sources of information.
  • Ability to proactively influences designs to achieve product quality and reliability targets that meet or exceed customer expectations.
  • Strong computers skills demonstrating a firm knowledge of Microsoft Office software (Word, Excel, PowerPoint, Outlook, and Microsoft Project).
  • Able to type 50 WPM.
  • Certified Quality Engineer preferred.
  • Master's Degree in related field preferred.
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