Associate Manager, Medical Device Quality (Sustaining Engineering)

Role Summary

Associate Manager, Medical Device Quality (Sustaining Engineering) oversees the medical device quality function, including combination products such as pre-filled syringes and auto-injectors/pen injectors for biological therapeutics developed internally and in collaboration with partners and contract manufacturers. The role applies quality risk management principles to medical device development and commercialization and collaborates with internal and external partners, primarily on post-transfer and commercial activities. The position leads sustaining engineering QA activities and provides QA oversight across the lifecycle of combination products.

Responsibilities

• Provide leadership to the team, including sustaining engineering support.
• Support sustaining engineering programs through risk evaluation, design changes, and maintaining the design history file.
• Advise and participate in Design Reviews associated with combination products and/or medical devices.
• Maintain the quality risk management file for commercial combination products, including data-driven risk assessments (risk identification, analysis and ranking).
• Provide QA oversight and support to combination products in the sustainability phase of commercialization.
• Provide technical support to quality engineers and regulatory team during maintenance of the combination product.
• Responsible for the management and development of quality engineering team members.
• Represent the medical device quality management system during regulatory inspections and partner audits.
• Interact with partners and contract organizations to ensure accurate completion of project achievements, including impact of changes and post-commercialization activities.

Qualifications

• Thrive in a quality-focused environment.
• Proven experience in global applications of Quality Assurance and Quality Risk Management in the medical device/combination products field.
• Possess excellent written, oral, and interpersonal communication skills with the ability to effectively interact with a broad spectrum of audiences.
• Associate Manager – 6+ years; Manager – 7+ years of related pharmaceutical/medical device/biotechnology industry experience (level determined by qualifications).

Education

• Bachelor's degree in Mechanical or Biomedical Engineering or equivalent.

Skills

• Quality Assurance
• Quality Risk Management
• Design Reviews
• Regulatory Inspections and Audits
• Team Leadership and Development
• Cross-functional Collaboration with internal and external partners