Senior Quality Engineer - Post-Market & Process Improvement

Boston Scientific; Marlborough (MA); Hybrid; USD 85,000 - 162,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Boston Scientific is seeking a Senior Quality Engineer in Massachusetts to support post-market complaint handling. You will establish controls, oversee regulatory compliance, and lead cross-functional teams to improve process effectiveness and reliability.

The role requires 5+ years in a quality control role within a regulated industry, SPC expertise, and familiarity with medical device regulations. Hybrid work in Marlborough, MA is required.

Qualifications

• Bachelor's degree in industrial engineering, statistics, sciences or related technical discipline.
• Minimum of 5 years' experience in a quality control-related role within a regulated industry (medical devices/pharmaceuticals preferred).
• Experience with statistical process control (SPC) and other statistical tools for quality data analysis.
• Experience managing cross-functional projects in a regulated environment.

Responsibilities

• Establish robust process controls for complaint handling outputs to ensure alignment with customer requirements and reliable performance.
• Apply expertise in quality control, SPC and systems thinking to drive continuous improvement of the complaint handling process.
• Evaluate end-to-end complaint handling from intake to adverse event reporting to identify bottlenecks and mitigate risk.
• Lead and participate in root cause investigations for recurring process failures and implement CAPAs.
• Collaborate with Quality, Post-Market Surveillance, Risk Management, IT and Systems teams to support effectiveness and compliance.
• Provide technical leadership to a team of global and divisional subject matter experts.

Skills

Quality control

SPC

Cross-functional collaboration

Regulatory compliance

Data analysis

Education

Bachelor's degree in industrial engineering, statistics, sciences or related technical discipline

ASQ CQE or similar certification

Tools

Statistical tools

Job description

Boston Scientific is seeking a Senior Quality Engineer in Massachusetts to support post-market complaint handling. You will establish controls, oversee regulatory compliance, and lead cross-functional teams to improve process effectiveness and reliability.

The role requires 5+ years in a quality control role within a regulated industry, SPC expertise, and familiarity with medical device regulations. Hybrid work in Marlborough, MA is required.