Senior Supplier Quality Engineering Leader (Hybrid)

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

Benefits offered by this job

Hybrid work arrangements

Bonus program

Generous PTO and paid holidays

Tuition reimbursement

Job summary

Nova Biomedical seeks a Senior Supplier Quality Engineer to lead a team ensuring supplier qualification, process validation, and ongoing performance improvements. You will oversee design transfer, NPI, and manufacturing support, driving APQP and risk-based strategies with suppliers and internal teams.

You’ll apply statistical methods and ISO 14971/13485 knowledge to reduce defects, improve capability, and support quality goals across lifecycle stages.

Qualifications

• Bachelor's degree in Engineering required.
• Minimum 7+ years in Supplier Quality/Manufacturing/Quality Engineering in a regulated industry.
• Leadership experience in engineering teams.
• Strong understanding of manufacturing processes, validation methodologies, and problem-solving.

Responsibilities

• Lead and develop a team of Supplier Quality Engineers for supplier qualification and process validation.
• Provide engineering oversight across design transfer, NPI, manufacturing, and sustaining operations.
• Drive APQP activities and risk-based qualification strategies for new suppliers and components.
• Lead supplier process validation and qualification efforts, including IQ/OQ/PQ activities and capability studies.
• Lead root cause investigations for supplier-related nonconformances and implement corrective actions.
• Collaborate with suppliers to improve process controls, inspection strategies, and yields.

Skills

Supplier Quality Engineering

APQP

Risk management

8D/DMAIC

Statistical methods

ISO 14971

ISO 13485/FDA QSR

Data-driven engineering

Process improvement

Education

Bachelor's degree in Engineering

Tools

SPC

Process capability analysis

DOE

Sampling plans

Trend analysis

IQ/OQ/PQ

Job description

Nova Biomedical seeks a Senior Supplier Quality Engineer to lead a team ensuring supplier qualification, process validation, and ongoing performance improvements. You will oversee design transfer, NPI, and manufacturing support, driving APQP and risk-based strategies with suppliers and internal teams.

You’ll apply statistical methods and ISO 14971/13485 knowledge to reduce defects, improve capability, and support quality goals across lifecycle stages.