Roles & Responsibilities:Strong Experience with Test Method Validation and MSAs.
Strong Risk Management Experience (Experience in Risk Documentation: Write, review, approve multiple quality records includes but not limited to: Design Files, Risk Management files, RPM P1 and P2 calculations, Risk Mitigations, etc.)Bachelor's degree in engineering field.Minimum of 4+ years of work in medical device industry experience in Engineering, Quality and Supplier Quality OR Advanced degree in Engineering field with 2+ years of work in medical device industry experience in Engineering, Quality and Supplier Quality with Strong Experience in Validation/Qualification activities: (Write, coordinate, execute, create reports, IQ, OQ, PQ, MVPR, Sampling size determination: For Attribute or variable data, Strong statistical background, PPAP review, etc.)Able to work and perform labour-intensive quality engineering hands-on activities, with minimum of supervision in a hybrid working organization set up.Good writing and documentation skills.Good organizational and verbal communication skills.Ability to work in fast-track schedule and meet deliveries on time.Ability to communicate effectively.Ability to interact with a very diverse team keeping high ethics standards.Demonstrate commitment with the Healthcare's Core Values.ASQ Quality Engineer Certification.Bilingual English/Spanish preferred but not required.Previous Healthcare and/or Medical Device experience is helpful.DMAIC Lean / Six Sigma Certification.Manufacturing experience within a controlled and regulated industry.