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:

1. Official ISO 9001/13485, cGMP, and FDA certifications and trainings
2. Advanced degree in quality management
3. Lead auditor for a regulatory agency
4. Lean Six Sigma Greenbelt or Blackbelt
5. 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.