What are the responsibilities and job description for the Manufacturing Quality Engineer position at Eurofins USA Genomic Services?
Job Description
Manufacturing Quality Engineer main purpose is to ensure that all manufacturing processes are in control and conforming to Eurofins Genomics process specification that then deliver products that meet aligned upon customer requirements.
Overall Objectives and Responsibilities :
Root Cause liaison for internal and external quality complaints. Leader in driving root cause analysis to identify root causes (man, method, material, measurement, machine) and put in place immediate containment, correction, and corrective actions in a timely manner. Collect Voice of the Customer (VoC) and provide details directly to customer on resolution. Demonstrates good cross functional coordination and leadership.
Containment : Steps in place to contain issue and be sure that more failures are not sent to customer(s)
Correction : Actions to correct the experience by customer (replace, adjust normalized product, etc)
Corrective Action : Actions to address root cause of problem (change of procedure, process, additional training, etc).
Lead individual assigned to Monitoring and Measuring of Process
Lead QA Check Process – store and deliver results of checks to management in report
Lead Layered Process Audits – audit processes that are considered highest impact to product conformity or were identified as a potential issue based on prior non-conformances
Lead QA Internal Audits assembles and leads site-wide internal audit team to support in identification of non-conformities and works with management to close non-conformities in a timely manner.
Lead Cleaning / Workplace Organization / 5S Audits audit to ensure conformance to workplace standards
Identifies and establishes statistical process controls (SPCs) of incoming raw and in-process materials according to a risk to poor quality matrix. Develop containment / control procedures to support in actions for maintaining quality control.
Daily process walks with area leaders to observe potential issues or opportunities
Initiate action to prevent the occurrence of non-conformities related to product, processes and quality systems.
Leads projects to improve the quality of manufacturing processes and products
Keeps up to date knowledge on all ISO and FDA regulatory standards, including attending sanctioned trainings
Performs other tasks as required by Quality Manager and Quality Director
Qualifications
Requirements :
BA / BS degree, preferred MS or higher
Technical knowledge of QSR, ISO 9001 / 13485, cGMP, and FDA QSR 21 CFR 820
Minimum 2 years’ experience in a quality position, medical device field preferred
Demonstrates sound judgment and willingness to contribute as a team member
Proven analytical and problem solving skills and excellent organizational skills
Preferred Training and Qualifications :
Official ISO 9001 / 13485, cGMP, and FDA certifications and trainings
Advanced degree in quality management
Lead auditor for a regulatory agency
Lean Six Sigma Greenbelt or Blackbelt
Proficiency in Microsoft Excel, MiniTab, or other tools for statistical analysis.
Additional Information
Schedule :
Monday-Friday 8 : 00am-5 : 00pm
What we offer :
Excellent full time benefits including comprehensive medical coverage, dental, and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
Eurofins is a M / F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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