Quality Manager, Engineering

  • Full-time

Company Description

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.

In 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

EAG Laboratories, part of the Eurofins group, is a leader in advanced microscopy, surface analysis and semiconductor testing services of various types of materials from synthetic biomaterials to nanotechnology, deliver new “super materials” with the potential to transform our world. Our laboratories are at the forefront of this revolution, providing the scientific expertise and analytical techniques to support companies at every phase of the product lifecycle, from R&D to manufacturing.

Our clients include leading edge tech companies in a diverse range of industries and business sectors who design, manufacture or incorporate products for tomorrow’s technology driven world. Our scientists and engineers engage in peer-to-peer interaction to discuss and comprehensively understand client issues, challenges, goals and urgency, to define the technical problems, develop and execute analyses, and report back results. We have a growth mindset culture where individuals are encouraged to drive their own success and make their own decisions while fulfilling client needs. 

The Quality Manager together with operations plans, coordinates, and maintains Quality Assurance in compliance with all policies, procedures, customer specifications, and regulatory requirements. The Quality Manager will work collaboratively with the laboratory management team to improve overall laboratory performance in key areas; Monitoring Compliance to customer specs, Standardized Operating Procedures (SOPs), Auditing internal and external and Customer/Consumer Complaints. This position is a leadership role, and as such is expected to inspire employees to greater levels of professionalism, quality, productivity, and engagement with the team. Support and implementation of a Culture of Quality is paramount. 

EAG Laboratories operates in accordance with International Traffic in Arms Regulation ITAR. Quality Manager must be a US Person (Citizen or Permanente Resident) as this person will be exposed to managing, sharing, safeguarding, and disseminating technical information in accordance with policy and law ( ITAR, 22 CFR §120-130).

Essential Job Functions:

  • Experience with compliance of ISO management systems
  • Works closely with operations to ensure daily operations follow policies, procedures, customer requirements, and local, state, and federal regulations
  • Responsible for defect identification, documentation, communication, and resolution
  • Management of Incoming and Outgoing Quality Inspection process and staff, trending and reporting results
  • Ensures escalation of non-conformance events to the proper operations and corporate QA personnel

Customer Specification Management

  • Participates in the review of new and revised versions of policies and procedures
  • Monitors compliance to customer specifications and communicates any issues/concerns
  • Works with operations to resolve any client concerns or complaints

Standardized Operating Procedures (SOP’s)

  • Ensures laboratory personnel have access to the most recent versions of the Corporate Standardized SOP’s and that all training records are current
  • Prepares laboratory specific versions of SOP’s as directed by the Director of Quality and Compliance
  • Ensures all forms and work instructions are linked to the laboratory SOP’s and are reviewed, revised, and updated annually

Auditing

  • Leads internal, customer, corporate, and regulatory audit visits
  • Engages appropriate operations management to ensure audit responses are completed in the allotted time frame and sustainable corrective actions are identified, agreed to, and implemented within defined time lines

Customer/Consumer Complaints

  • Manages the laboratory investigation for all complaints
  • Ensures timely response and a thorough review of all records
  • Provides written reports to corporate QA Director
  • Conducts investigations into incidents and quality issues
  • Document findings, performs trend analysis, and communicates to management, employees, and customers as appropriate
  • Record Review:  Ultimate oversight to ensure all record review is current for laboratory, sanitation, and production documents
  • Facilitates scheduling and/or delivery of quality/safety training to meet corporate and regulatory requirements
    • Completes training as required, to maintain license and certifications required by the position
  • Maintains current knowledge through seminars and industry publications to develop skills and improve job performance
  • Protects confidential information and proprietary processes

Qualifications

Education and Experience: 

  • 5+ years of specifically related experience or a combination of education plus related or applicable work experience.  Experience should be in performing compliance and quality management in a scientific setting.  Material characterization experience highly desirable. Training is done with a mentor and is documented in the training files.  Certification and Licenses a plus
  • Demonstrate technical expertise in Quality Management and experience in analytical service. Training is done with a mentor and is documented in the training files.

  • Working knowledge of Microsoft Outlook and Excel is required.  Knowledge of Word, LMS Systems, and PowerPoint is highly desirable

  • Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.  Knowledge of laboratory statistics may be necessary.

  • Ability to define and solve practical problems, present solutions, establish facts, and draw valid conclusions. Able to deal with a variety of concrete variables in situations where only limited standardization exists.  Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

  • Ability to read, analyze, and interpret professional journals, technical procedures, or government regulations. Able to read and interpret document such as study protocols, standard operating procedures, safety policies, instrument operation and maintenance instructions, and procedure manuals.  Able to summarize data and results.  Able to write reports, correspondence, and procedure manuals.  Ability to effectively present information and respond to questions from groups of managers, clients, customers, and others 

Additional Information

All your information will be kept confidential according to EEO guidelines.

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

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