Sr Quality Engineer

Join to apply for the Sr Quality Engineer role at Katalyst CRO
.

• 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.
• Manufacturing experience within a controlled and regulated industry.

Associate

Contract

Quality Assurance

Pharmaceutical Manufacturing