Quality Engineer

3 weeks ago

Huntington, United States Astrix Full time

Exciting development opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world – with complementary businesses in Surgical and Vision Care.


The Senior Quality Engineer I


  • Working with the Quality, Manufacturing and MS&T Engineering teams to support activities during the overall product life cycle.
  • Lead and support continuous improvement projects, quality issue resolution, Non-conformances/CAPAs, process controls, and validations.



MUST HAVES:


  • Previous experience in Med Device and Pharma
  • Validation Experience


Job Responsibilities:

• Provides quality support to manufacturing operations including providing guidance on issue resolution, follow up on potential quality concerns, continuous improvement project support, and daily walk throughs.


• Investigates, approves, and/or provides input on minor and major non-conformance events (NC) and Corrective Actions and Preventive Actions (CAPA). Uses various statistical and non-statistical problem-solving tools to analyze data or issues and to identify/drive improvement opportunities.


• Tracks and trends CAPA system data with minimal guidance using various statistical and non-statistical problem-solving tools as part of analysis.


• Leads and supports medium to large size projects to reduce/prevent nonconformance events and/or projects to enhance the Quality Management System (QMS).


• Provides day-to-day Quality mentoring, assistance, and support to QE 1s and other departments (i.e., Manufacturing engineers, engineers, etc.) related to quality, compliance to regulatory standards, root cause investigations & investigation tools, risk management, validation concepts, general process challenges, and troubleshooting on the assigned projects/processes, including event identification and quarantine processes.


• Performs quality approval on various documents such as: SOP's/Work instructions/Job aids/Controlled Forms, technical reports, drawings, calibration/maintenance assessments and procedures, pre-qualification and validation documentation, and FMEAs.


Qualifications:

• Bachelor’s Degree in Science/Engineering or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)

• 2+ Years of experience in Pharmaceutical / Medical Device Industry

• Project management experience

• ASQ CQE certification (or equivalent) preferred.

• Understands statistical principles.

• Experience in SAP/BI


This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you

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