Senior Lead, Supplier Quality Engineering

Nova Biomedical; Waltham (MA); Hybrid; USD 130,000 - 150,000; Full time

Benefits offered by this job

Hybrid work arrangements

401(k) company match

Bonus program

Generous PTO and holidays

Tuition reimbursement

Job summary

Nova Biomedical in Massachusetts is seeking a leader for Supplier Quality Engineering to drive supplier qualification, process validation, and continuous improvement across the product lifecycle. You will partner with R&D, Manufacturing, and suppliers to ensure high quality components meet regulatory requirements.

The role requires a Bachelor's degree in Engineering and 7+ years in supplier quality or related engineering roles, plus prior people leadership.

Qualifications

• Bachelor's degree in Engineering required.
• 7+ years of progressively responsible experience in supplier quality or related engineering roles in a regulated industry.
• Previous people leadership or engineering management experience.
• Experience qualifying suppliers, manufacturing processes, and critical components.
• Strong knowledge of ISO 14971, ISO 13485, FDA QSR, and supplier quality in medical devices.

Responsibilities

• Lead and develop a team of Supplier Quality Engineers responsible for supplier qualification, process validation, and ongoing supplier engineering performance improvement.
• Provide engineering oversight of supplier quality activities across design transfer, NPI, manufacturing, and sustaining operations.
• Partner with R&D, Manufacturing, and Operations to evaluate and qualify suppliers and components.
• Drive APQP activities and risk-based qualification strategies for new suppliers and components.
• Lead supplier process validation, IQ/OQ/PQ, capability studies, and manufacturing readiness assessments.

Skills

Supplier Quality Engineering

Leadership

Manufacturing Engineering

Statistical methods

Risk management

Root cause analysis

Education

Bachelor's degree in Engineering

Tools

SPC

Job description

Nova Biomedical in Massachusetts is seeking a leader for Supplier Quality Engineering to drive supplier qualification, process validation, and continuous improvement across the product lifecycle. You will partner with R&D, Manufacturing, and suppliers to ensure high quality components meet regulatory requirements.

The role requires a Bachelor's degree in Engineering and 7+ years in supplier quality or related engineering roles, plus prior people leadership.