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.