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.
Requirements
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 methodologies, critical thinking, and deductive skills.
Understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971. Knowledge of GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements (i.e., 21 CFR 820 in the United States).
Familiarity with design control processes to ensure that design/development, validation, and verification processes align with intended use and performance criteria.
The expected salary range for this position is $70,000 to $80,000 annually, depending on skills, experience, and qualifications
Freudenberg · Baldwin Park, CA