Research Manufacturing Engineer II

Primary responsibilities include driving improvements to the CORT QMS, overseeing and ensuring compliance with the CAPA, NC and Quality Planning processes, and providing experienced quality assurance support to manufacturing and product development teams. 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.

Position Summary:
This Engineer is responsible for supporting the Center for Orthopedic Research Translation (CORT) Quality Management System (QMS). CORT is a new entity within BCH whose purpose is to facilitate the development of novel orthopedic therapies. Primary responsibilities include driving improvements to the CORT QMS, overseeing and ensuring compliance with the CAPA, NC and Quality Planning processes, and providing experienced quality assurance support to manufacturing and product development teams. This role will provide training on QMS processes to the organization, champion the QMS and work on many phases or sub-tasks of projects or entire projects. Assisting with manufacturing duties will also be required. This position will work independently under general supervision.

Key Responsibilities:

• 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.

 
Minimum Qualifications
Education:

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

Experience:

• 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.