Associate Manager, Medical Device Quality (Sustaining Engineering)

Role Summary

Associate Manager, Medical Device Quality (Sustaining Engineering) leads QA oversight of medical device functions, including combination products such as pre-filled syringes and auto-injectors. Applies quality risk management principles to development and commercialization, collaborating with internal and external partners, primarily during post-transfer and commercial activities.

Responsibilities

• Provide leadership to the sustaining engineering team and support ongoing programs.
• Support sustaining engineering through risk evaluation, design changes, and maintaining the design history file.
• Advise and participate in design reviews for 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 during the sustainability phase of commercialization.
• Provide technical support to quality engineers and regulatory teams during maintenance of the combination product.
• Manage and develop quality engineering team members.
• Represent the medical device QMS during regulatory inspections and partner audits.
• Interact with partners and contract organizations to ensure accurate completion of project milestones, including post-commercialization activities and the impact of changes.

Qualifications

• Required: Bachelor's degree in Mechanical or Biomedical engineering or equivalent.
• Experience: 6+ years for Associate Manager; 7+ years for Manager in the pharmaceutical/medical device/biotechnology industry.

Skills

• Quality Assurance and Quality Risk Management in the medical device/combination products field.
• Strong written, oral, and interpersonal communication skills for diverse audiences.
• Leadership and team development capabilities.
• Experience with regulatory inspections and partner audits.

Education

• Bachelor’s degree in Mechanical or Biomedical engineering or equivalent.