Quality Engineer I
hace 3 semanas
Quality Consulting Group is seeking a highly motivated and enthusiastic Quality Engineer I to join our team in Puerto Rico & USA. In this role, you will work with a highly enthusiastic team, contributing to a world-class manufacturing industry. Your responsibilities will include formulating, delivering, and managing projects assigned, working with other stakeholders to achieve desired results, and developing, modifying, applying, and maintaining quality standards and protocol for processing materials into partially finished or finished materials product. You will collaborate with engineering and manufacturing functions to ensure quality standards are in place, devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment, and ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
Key Qualifications:
Bachelor's degree in engineering (Software, Mech, and Chem Engineering preferred)
4 years of relevant experience
Experience reviewing and approving validation test plans, reports, and deviations
Capable of performing statistical analysis to support validations and product release
Knowledgeable of medical devices manufacturing regulations
Ability to use statistical techniques to analyze data
Collaborative attitude
Experience in CSV
Experience in medical device industry
Experience in Process Validation and Equipment qualification
Experience in risk management documents (e.g. pFMEA)
Experience in manufacturing events investigations
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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