Quality Engineer / Process Support Investigator

As a Quality Engineer / Process Support Investigator, you will be responsible for performing complex multivariate analysis and creating complex graphs and charts within the manufacturing/healthcare industry. You will also support product and process evaluation activities associated with product complaints to ensure constant improvement in quality and operational practices.

Additional and responsibilities for the Quality Engineering position include:

• Creating objective, thorough documentation of investigation activities
• Ensuring that expectations in regard to investigations, corrections, CAPA’s, and all corresponding documentation are continually met
• Providing technical input and assisting in gathering appropriate operations and other functional inputs on issues
• Evaluating deliverables for compliance, completeness, and clarity, and providing feedback/disposition as appropriate
• Communicating significant issues or developments identified during quality assurance activities and recommend improvements
• Providing and presenting technical information to the team members and management

As a Quality Engineer / Process Support Investigator, you must possess excellent communication skills, both oral and written, to interpret scientific and technical journals, financial reports and legal documents. Additionally, you must have the problem-solving and critical thinking skills to identify issues, draw valid conclusions and deal with several abstract or concrete variables., * Bachelor’s degree in Life Sciences, Chemistry or Chemical Engineering, preferred

• 4 years of pharmaceutical experience or biotech industry performing similar duties
• 2-4 years in (Good Manufacturing Practice) GMP environment
• ASQ Certified Quality Engineer, Six Sigma Green Belt, preferred
• Proficient use of Quality Management Systems such as Trackwise
• Proficient use of Excel and statistical software (Minitab, Jump, etc.)
• Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, permutations, frequency distribution, and analysis of variance
• Strong Quality Investigation background with proven training, preferred

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care, We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.