Supplier Quality Engineering Manager

Nova Biomedical; Waltham (MA); Hybrid; USD 150,000 - 210,000; Full time

Benefits offered by this job

Medical, Dental, and Vision Coverage

Competitive 401(k) company match

Bonus Program

Generous PTO and paid holidays

Hybrid and flexible work arrangements

Employee engagement programs

Job summary

Nova Biomedical in Waltham, MA seeks a Supplier Quality Engineering Manager to lead a global supplier quality program across the product lifecycle. You will oversee supplier qualification, process validation, NPI, and manufacturing engineering support to ensure robust processes and regulatory compliance.

You will partner with R&D, Manufacturing Engineering, Operations, and external suppliers to drive risk-based supplier qualification, CAPA, and continuous improvement, while guiding audits and

Qualifications

• Bachelor’s degree in Engineering or related field.
• 7+ years in supplier quality engineering or related function within a regulated industry.
• Experience leading teams or engineering management.
• Strong understanding of manufacturing processes, validation, and problem solving.
• Knowledge of ISO 13485, MDSAP, 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 supplier performance improvement.
• Provide technical oversight of supplier quality activities across design transfer, NPI, manufacturing, and sustaining operations.
• Partner with R&D, Manufacturing Engineering, Supplier Development, Operations, and suppliers to qualify critical components, processes, and manufacturing capabilities.
• Lead APQP activities and risk-based supplier qualification strategies.
• Drive supplier process validation and engineering qualification, including IQ/OQ/PQ, process capability studies, and manufacturing readiness assessments.
• Apply statistical and quality engineering methods to evaluate supplier process capability, identify variation, and drive continuous improvement.
• Lead root cause investigations for supplier-related quality issues using 8D, DMAIC, Fishbone, and Five Whys.
• Lead investigation and trend analysis of supplier-related NCMRs and implement systemic corrective actions.
• Issue and manage SCARs, ensuring corrective actions are implemented and effectiveness is verified.
• Analyze supplier quality and engineering data to identify trends, reduce defects, improve process capability, and strengthen supply chain performance.
• Support design transfer by ensuring suppliers meet manufacturing, quality, engineering, and regulatory requirements before product launch.
• Evaluate supplier changes and determine appropriate validation, risk assessment, and engineering activities.
• Work directly with suppliers to improve process controls, inspection strategies, yield, manufacturing efficiency, and technical capability.
• Conduct supplier technical assessments and on-site evaluations of manufacturing processes, process controls, validation practices, and engineering capabilities.
• Serve as a Supplier Quality Engineering subject matter expert during internal audits, regulatory inspections, and ISO 13485, MDSAP, IVDR audits.

Skills

Leadership

Supplier Quality

Data-driven

Risk management

Cross-functional

Education

Bachelor's degree in Engineering

Tools

SPC

DOE

Sampling plans

Trend analysis

Job description

We are seeking a Supplier Quality Engineering Manager to lead the Supplier Quality Engineering function and drive technical quality and engineering performance across a global supply base.

This role will oversee supplier quality activities throughout the product lifecycle, including design transfer, new product introduction (NPI), supplier process qualification, incoming inspection, manufacturing engineering support, validation, and continuous improvement.

You’ll work closely with R&D Engineering, Manufacturing Engineering, Operations, Quality, and external suppliers to ensure robust engineering processes, effective risk management, and consistent delivery of high-quality components and materials that meet product, engineering, and regulatory requirements.

Responsibilities

• Lead and develop a team of Supplier Quality Engineers responsible for supplier qualification, process validation, and supplier performance improvement.
• Provide technical oversight of supplier quality activities across design transfer, NPI, manufacturing, and sustaining operations.
• Partner with R&D, Manufacturing Engineering, Supplier Development, Operations, and suppliers to qualify critical components, processes, and manufacturing capabilities.
• Lead APQP activities and risk-based supplier qualification strategies.
• Drive supplier process validation and engineering qualification, including IQ/OQ/PQ, process capability studies, and manufacturing readiness assessments.
• Apply statistical and quality engineering methods to evaluate supplier process capability, identify variation, and drive continuous improvement.
• Apply ISO 14971 risk management principles to identify and mitigate supplier-related product and manufacturing risks.
• Lead root cause investigations for supplier-related quality issues using methodologies such as 8D, DMAIC, Fishbone, and Five Whys.
• Lead investigation and trend analysis of supplier-related NCMRs and implement systemic corrective actions.
• Issue and manage SCARs, ensuring corrective actions are implemented and effectiveness is verified.
• Analyze supplier quality and engineering data to identify trends, reduce defects, improve process capability, and strengthen supply chain performance.
• Support design transfer by ensuring suppliers meet manufacturing, quality, engineering, and regulatory requirements before product launch.
• Evaluate supplier changes and determine appropriate validation, risk assessment, and engineering activities.
• Work directly with suppliers to improve process controls, inspection strategies, yield, manufacturing efficiency, and technical capability.
• Conduct supplier technical assessments and on-site evaluations of manufacturing processes, process controls, validation practices, and engineering capabilities.
• Serve as a Supplier Quality Engineering subject matter expert during internal audits, regulatory inspections, and ISO 13485, MDSAP, and IVDR audits.

Qualifications

• Bachelor’s degree in Engineering, such as Mechanical, Manufacturing, Industrial, Biomedical, Chemical Engineering, or a related engineering discipline.
• 7+ years of progressively responsible engineering experience in Supplier Quality Engineering, Manufacturing Engineering, Quality Engineering, Process Engineering, or a related technical engineering function within a regulated industry.
• Previous people leadership or engineering management experience.
• Strong understanding of manufacturing processes, process controls, validation methodologies, and engineering problem-solving.
• Demonstrated experience qualifying suppliers, manufacturing processes, and critical components.
• Proven ability to drive supplier defect reduction and process capability improvements using data-driven engineering approaches.
• Working knowledge of statistical quality tools including SPC, process capability analysis, DOE, sampling plans, and trend analysis.
• Experience conducting root cause investigations and implementing corrective and preventive actions with suppliers.
• Strong understanding of engineering risk management and ISO 14971.
• Working knowledge of ISO 13485, MDSAP, FDA Quality System Regulation, and supplier quality requirements within medical device or life sciences environments.
• Experience supporting design transfer, process validation, manufacturing scale-up, and NPI.
• Strong technical communication and stakeholder management skills with the ability to influence suppliers and cross-functional engineering teams.

Required Skills

• Strong understanding of manufacturing processes, process controls, validation methodologies, and engineering problem-solving.
• Demonstrated experience qualifying suppliers, manufacturing processes, and critical components.
• Proven ability to drive supplier defect reduction and process capability improvements using data-driven engineering approaches.
• Working knowledge of statistical quality tools including SPC, process capability analysis, DOE, sampling plans, and trend analysis.
• Experience conducting root cause investigations and implementing corrective and preventive actions with suppliers.
• Strong understanding of engineering risk management and ISO 14971.
• Working knowledge of ISO 13485, MDSAP, FDA Quality System Regulation, and supplier quality requirements within medical device or life sciences environments.
• Experience supporting design transfer, process validation, manufacturing scale-up, and NPI.
• Strong technical communication and stakeholder management skills with the ability to influence suppliers and cross-functional engineering teams.

Preferred Skills

• Previous people leadership or engineering management experience.
• Experience in medical device or life sciences environments.

Pay range and compensation package

What’s Offered

• Medical, Dental, and Vision Coverage
• Competitive 401(k) company match
• Bonus Program
• Generous PTO and paid holidays
• Hybrid and flexible work arrangements
• Employee engagement programs and events
• Company-provided lunch and snacks at select locations
• Subsidized cafeteria at the Waltham office

Physical Requirements

• Ability to carry up to 25 pounds.
• Ability to work at a desk for extended periods.