Manufacturing Quality Engineer - Eurofins PSS Insourcing Solutions, LLC

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

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

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.

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.