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Quality Engineer II

San Diego , CA

Posted: 02/16/2023 Industry: Engineering and Technical Job Number: 15347

Job Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services while treating candidates with the professionalism and respect they deserve.

Title: Quality Engineer 
Hiring Organization: Connexion Systems & Engineering
  • Duration: Temp to Perm
  • Pay rate: $64.28/hr
  • Job Location: San Diego, CA
  • Job# 15347

Job Summary
The Quality Engineer II is responsible for validation of analytical methods, cleaning, production process, equipment qualification, facilities/utilities qualification, and raw materials qualification. Additionally, generate and maintain process FMEA for production processes, perform risk assessments for process related non-conformances and planned deviations, provide support and content for regulatory submissions, write master validation plans, protocols and reports, support equipment and facilities change controls, and perform validation impact assessment for change orders.

Essential Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
  • Author master validation plans and reports.
  • Author and execute validation protocols and reports (Analytical Methods, Equipment, Facilities/Utilities, Raw Materials, Process, and Cleaning).
  • Review the quality, validation impact, and completeness of document change order requests and change controls (Equipment or Facilities).
  • Determine validation strategy based on acceptable risk-based approach.
  • Lead cross-functional team to write PFMEAs under limited supervision.
  • Perform process risk assessment for Non-Conformance Events (NCEs) and planned deviations (PDV).
  • Assist in maintaining validation records.
  • Support cross-functional teams during New Product Introduction (NPI) and Sustaining projects.
  • Review regulatory submissions and/or notifications under limited supervision.
  • Propose improvement projects with supporting data, flowcharts, etc.
  • Assist in developing/updating departmental procedures and other controlled documents.
  • Evaluate adequacy of specifications for new or modified process designs under limited supervision.
  • Lead department and cross-department projects under limited supervision. Determine QE deliverables and assist in generating project timelines.
  • Participate in process design reviews.
  • Assist QE management in Material Review Board (MRB) and Production Response Team (PRT) meetings.
  • Participate in department process improvement’s goal(s).
  • Assist in development, maintenance, and reporting of department metrics.
  • Provides management with status updates on assigned responsibilities, goals and escalate issues in a timely fashion.

Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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Meet Your Recruiter

Emily Donahue
Regional Recruiting Manager

  • Directthe recruitment efforts for both the Quincy, MA and Providence, RI branches. 
  • Manages a distributed team of recruiting leads, individual contributor recruiters and account managers. 
  • Responsible for leading the fulfillment and execution of sourcing, recruiting, sales and business development practices across the region. 
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