Senior Supplier Quality Engineer

TL;DR

Senior Supplier Quality Engineer (Medtech): Maintain and improve the Quality System for surgical robotics devices within FDA QSR, ISO 13485, and EU MDR requirements with an accent on supplier assessments, audits, and performance management. Focus on resolving non-conformances, implementing corrective actions, and supporting process validations using tools like 8D, FMEA, and SPC.

Location: San Jose, CA - On-site. Ability to travel up to 25% domestically and internationally for supplier audits and visits.

Company

hirify.global revolutionizes treatment for benign prostatic hyperplasia (BPH) through innovation in surgical robotics.

What you will do

• Conduct supplier assessments and audits to ensure compliance with Procept and regulatory requirements.
• Develop supplier performance scorecards and lead periodic reviews with improvement plans.
• Lead resolution of supplier non-conformances using problem-solving tools like 8D, Fishbone, and 5 Whys.
• Support supplier process validations (IQ, OQ, PQ) and assess impact of manufacturing changes.
• Collaborate with R&D, Procurement, Manufacturing, and Regulatory Affairs on supplier initiatives and new product introductions.
• Oversee compliance with environmental regulations like REACH, RoHS, and Conflict Minerals.

Requirements

• Bachelor's degree in engineering or scientific discipline.
• 5+ years in manufacturing finished medical devices or related industry.
• Working knowledge of FDA QSR, ISO 13485, ISO 14971, and EU MDR.
• Knowledge of statistical quality control, DOE, Minitab; Six Sigma Green or Black Belt preferred.
• Strong analytical, problem-solving, and communication skills; GD&T knowledge preferred.
• Lead auditor credentials desired; ability to travel up to 25%.

Culture & Benefits

• Comprehensive health coverage, wellness programs, on-site gym.
• 401(k) with employer match, short/long-term disability, life insurance.
• Flexible/PTO, paid parental leave, paid holidays.
• Focus on work/life blend, continuous career growth, cross-functional team building.
• Pathological optimism, curiosity, ingenuity in innovative environment.