Associate Manager, Medical Device Quality (Sustaining Engineering)

Role Summary

Associate Manager, Medical Device Quality (Sustaining Engineering) – Provide QA oversight of the Medical Device function including combination products, with focus on sustaining engineering and post-transfer/commercial activities. Collaboration with internal and external partners and regulatory bodies to apply quality risk management to development and commercialization.

Responsibilities

• Provide leadership to the quality engineering team and sustaining engineering support.
• Support sustaining engineering programs through risk evaluation, design change, and maintenance of 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 with data-driven risk assessments.
• 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.
• 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 achievements and post-commercialization activities.

Qualifications

• Required: Bachelor‚Äôs degree in Mechanical or Biomedical engineering or equivalent.
• Experience: Associate Manager ‚Äì 6+ years; Manager ‚Äì 7+ years in pharmaceutical/medical device/biotechnology industry.

Skills

• Proven experience in global applications of Quality Assurance and Quality Risk Management in medical device/combination products.
• Excellent written, oral, and interpersonal communication skills suitable for diverse audiences.

Education

• Bachelor‚Äôs degree in Mechanical or Biomedical engineering or equivalent.

Additional Requirements

• None specified beyond role qualifications.