Quality Engineer I

Job description

Working at Freudenberg: We will wow your world! Responsibilities: Understand quality system requirements to support the development, qualification and manufacturing of products to meet internal and external requirements. Utilize statistical analysis tools to support project team. Support creation of Master Validation Plan, validation protocols and reports (IQ/OQ/PQ), quality design reviews deliverables, risk management plan, and all quality related documentation. Assist in and may lead supporting nonconformances, complaints, CAPAs, etc. to resolve quality issues. Support internal and external audits, ensuring quality system compliance . Support Measurement System Analysis (MSA), including Gage R&R, test method validations. Qualifications: Bachelor's/University degree in Engineering, Chemistry, Biology, or related science/technical field. 0-3 years’ experience in Medical Device or a related regulated industry. Knowledge of statistical methods, process control, and the use of quality tools such as Design of Experiments (DOE), Failure Mode and Effects Analysis (FMEA), Control Plan, MSA, SPC, as well as GD&T and fixturing. Demonstrated experience with formal problem-solving methodologi...