Research Manufacturing Engineer II

• Maintain and improve the QMS to ensure compliance with regulatory requirements and internal procedures.
• Manage and update the Quality Manual and site quality procedures to keep documentation accurate, effective, and aligned with business needs.
• Identify nonconformances and support complaint handling, investigations, and CAPA initiation, tracking, and closure.
• Oversee the internal audit program and provide quality expertise during external audits and regulatory inspections.
• Monitor, analyze, and report quality metrics and key performance indicators to drive compliance and prevent recurring issues.
• Provide quality assurance support across manufacturing, product development, procurement, and other cross-functional teams.
• Lead CAPA, quality review, and process improvement meetings, ensuring timely communication, issue resolution, and project progress reporting.
• Drive continuous improvement initiatives using quality tools and methodologies such as Lean, Six Sigma, Poka-Yoke, and data analysis, while supporting special projects and inventory-related quality activities.

• Bachelor's degree in an engineering discipline is required (Biomedical Engineering preferred).

• Minimum of 4 years' experience in the medical device or pharmaceutical industry.
• Previous CAPA and/or quality systems/assurance experience and demonstrated use of quality tools/methodologies.
• Detailed knowledge of FDA Quality Systems Regulations, GMP, ISO 13485 and other global regulations and standards.
• Previous experience in manufacturing environment (Medical Device preferred).
• Strong verbal and written communication skills with the ability to communicate effectively at multiple levels of the organization.
• Demonstrated organizational skills with the ability to multitask, prioritize and meet deadlines.

The posted pay range is Boston Children's reasonable and good-faith expectation for this pay at the time of posting.

Any base pay offer provided depends on skills, experience, education, certifications, and a variety of other job-related factors. Base pay is one part of a comprehensive benefits package that includes flexible schedules, affordable health, vision and dental insurance, child care and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork.