Quality Assurance Compliance Manager

Philadelphia, PA

Posted: 07/18/2019 Industry: Laboratory - Industrial Chemicals Job Number: 323.19CM Pay Rate: 110,000 - 125,000

Job Description

Quality Assurance Compliance Manager

DUTIES:

The Challenge

Assume that company products are of consistently high quality by managing, maintaining, continually improving, where applicable, and assisting in the operation and development of the Quality Management Systems (QMS), requirements, and execution for company.

 The Position

  • Build and maintain the Quality Management Systems in line with regulatory environment and business ambitions and market developments
  • Implement and manage effective quality controls throughout the organization to assure quality compliance to the quality Management system
  • Build a quality culture together with the key stakeholders; Why-What-How supported by metrics
  • Manage regulatory inspections and customer audits including proactive preparation for the inspections / audits and practical, compliant response to findings
  • Manage and control concerns / feedback from the market (PMS-customer complaints) and drive improvements in product and process
  • Continuously drive the improvements on quality performance and effectiveness of the site. Leverage learnings to company.
  • Manage the recall process and use proactively, including through CAPA’s, to drive process and product improvements

**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:  323.19CM
#LI-CM1

Job Requirements

Requirements:

  • Bachelor’s degree in Engineering or related field and/or equivalent experience within the medical device field
  • Auditing certification(s) preferred
  • 5-10 years’ experience in QA/QC in Medical Device Manufacturing. Will have a minimum of 10 years progressive experience with quality processes and systems in a regulated environment (life science) within an international fast growing / changing environment.  Experience must include influencing and directing the work of others both functionally and cross-functionally
  • Quality standards ISO13485 & MDD – MD SAP is a strong plus
  • FDA Regulations & Guidelines, 21 CFR820, GMP/QSR
  • Excellent knowledge of management systems
  • Excellent knowledge of Quality Assurance processes, continuous improvement processes
  • Change management / processes and team building skills
  • Knowledge of systems: Oracle and SAP
  • Previous supervisory experience, someone that is not stranger to leadership as a working manager

**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:  323.13CM

#LI-CM1

 

Meet Your Recruiter

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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