Quality Engineer II: Process & Quality Assurance

Boston Scientific; California (MO); On-site; USD 52,000 - 99,000; Full time

Job summary

Boston Scientific is hiring a Quality Engineer II to provide process and quality engineering support to manufacturing and product development teams, ensuring the delivery of high-quality medical devices. You will participate in root-cause analysis, develop quality plans, and foster improvements across processes and products.

The role demands knowledge of quality systems, risk analyses, and data-driven problem solving, with flexibility to work multiple shifts in a fast-paced environment.

Qualifications

• Bachelor’s degree in engineering with at least 3 years of experience.
• Knowledge of Quality System Mfg Process.
• General knowledge of industry practices, techniques, and standards.
• Knowledge of standard statistical analysis techniques and problem-solving methodologies, including capability studies.
• Medical Device Manufacturing Process expertise.
• Knowledge of Quality and Traceability Systems (MESS/SAP/eCAPA/Windchill).
• General knowledge of quality metrics.
• Flexibility to work other shifts as needed.
• Fully bilingual.

Responsibilities

• Identifies and controls manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in cross-functional teams and implementing corrective actions.
• Develops product quality plans, documents and systems with specifications and quality plans.
• Develops Process Monitoring Systems to reduce process variation and defects.
• Leads process improvement efforts and quality data analyses to enhance product design and development.
• Assists in creation of Quality Tools & Training Materials and improves tooling.
• Evaluates adequacy and compliance of systems, operations, and practices against regulations and documentation.
• Responsible for final Process Monitor Release for products prior to distribution.

Skills

Statistical analysis

Problem solving

Quality metrics

Shifts flexibility

Bilingual

Education

Bachelor’s degree in engineering

Job description

Boston Scientific is hiring a Quality Engineer II to provide process and quality engineering support to manufacturing and product development teams, ensuring the delivery of high-quality medical devices. You will participate in root-cause analysis, develop quality plans, and foster improvements across processes and products.

The role demands knowledge of quality systems, risk analyses, and data-driven problem solving, with flexibility to work multiple shifts in a fast-paced environment.