Job Description & Skill Requirement:

- Lead, support, review, and approve supplier change requests, Validation, MSA, SCAPA, TMV, PPAP, Risk Assessment etc.

- Work with new and existing CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities, including SPC, Quality Plans, Control Plans, and FMEAs

- Familiar with the Medical industry requirements such as ISO 13485

- Ensures that suppliers deliver quality parts, materials, and services

• Bachelors degree required

• Minimum of 3 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

• Excellent communication and technical writing skills

• Experience in Manufacturing and/or Electro-Mechanical Medical Device risk assessments

• Working knowledge of Quality System Regulation (QSR 21 CFR 820) and EU Medical Device Directive (EU MDD 93/42 EEC)

The expected salary range for this position is between $63,000 to $1,20,000 annually. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in role, base salary of internal peers, prior performance, business line, and geographic/office location.