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 P and P calculations, Risk Mitigations, etc.)

Bachelor's degree in engineering field.

Minimum of + years of work in medical device industry experience in Engineering, Quality and Supplier Quality OR Advanced degree in Engineering field with + 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.