Supplier Quality Engineer

Philadelphia, PA

Posted: 07/23/2019 Industry: Laboratory - Industrial Chemicals Job Number: 321.19CM Pay Rate: 95000

Supplier Quality Engineer

The Challenge

The Supplier Quality Engineer supports the BU regarding engineering activities for all product lines; qualifications, validations, data analysis, statistical process control (SPC), CAPA, KPI’s, Review, and Trending. Responsible for Supplier product-related root cause analysis, process mapping and impact assessments for change control. Lead in CMO/Supplier audits, establish actions as required.

 The Position

  • Develop, document, and implement QA Procedures
  • Perform external audits of CMOs/suppliers to appropriate criteria, report findings and develop actions as required.
  • Analyze non-conforming materials and returned goods and recommend disposition and corrective actions
  • Create suitable data analysis tables and report findings based on statistical evidence and trending.
  • Provide analytical investigations and develop root cause for non-conformances and deviations
  • Analyze data and generate summary reports
  • Interface with vendors as required
  • Review documentation for completeness and accuracy
  • Assist in the performance of qualification and validation studies
  • Complete other tasks as assigned by the Manager, QA
  • Work on occasion in a clean room setting following protective procedural requirements and comply with all safety requirements, including posted placards, SOPs and the Safety Manual.
  • Report any observed unsafe equipment, condition or practice immediately to a supervisor, management, or member of the Safety Committee.
  • Adhere to Quality System procedures, ISO13485, 21CFR part 820 and current regulatory standards.

**If you’d like to hear more about this opportunity and others we are currently working on, please contact Crystal Meeks at 815.756.1221 / cmeeks@cps4jobs.com.

JO:  321.19CM

#LI-CM1

 

Requirements

  • BS Degree in Quality, Science, or Polymer Engineering or equivalent undergraduate experience
  • ASQ QE or ASQ CQA Certification a plus
  • 4-6 years Quality Engineering within a QA/QC department at an FDA-Regulated, Medical Device, Pharmaceutical, Biotech, or other regulated industry
  • Demonstrated ability to multi-task resulting in positive outcome for each task assigned or self-generated
  • Experience with ISO -9001, or ISO 13485, or 21 CFR820 desired
  • Accommodate a minimum of 25% travel
  • Excellent organizational, leadership, decision-making, and analytical skills
  • Excellent written and verbal communication skills, including writing, editing and proofing skills
  • Well-developed inter-personal and teamwork skills to communicate and resolve product quality issues with R&D, Production, Engineering and other departments
  • Customer centric model, someone that will partner with the suppliers. Here is what we discovered and let’s work on a solution together.  Partnership vs. adversarial.
  • Metric oriented, but a strategic problem solver

**If you’d like to hear more about this opportunity and others we are currently working on, please contact Crystal Meeks at 815.756.1221 / cmeeks@cps4jobs.com.

JO:  321.19CM
#LI-CM1

 

Crystal Meeks
Sr. Technical Recruiter

Our Industrial Laboratory Recruitment Team specializes in placing candidates at all levels of the chemical development cycle from Laboratory Technicians to Executive Leadership in Research.  I joined CPS in 2011 as a full cycle recruiter and have expertise in the following areas:

 


Technical Leadership ~ Product Development ~ Organic and Polymer Synthesis 
Formulation ~ Research & Development 
Application Chemistry ~ Technical Service
Process Chemistry ~ Analytical Chemistry ~ Method Development
Regulatory Compliance ~ EH&S ~ Quality Assurance ~ Quality Control 

 

My recruitment philosophy encompasses the belief that people are the greatest asset in an organization.  Finding the right fit is not only about the technology.  It is about how an employee fits within an organization's culture and ensuring that both parties can add value to each other immediately and in the future.   

 

If you have interest in finding an opportunity that aligns with your career goals, or if you are a hiring manager looking for talent that can add value to your organization, I would love to hear from you!

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