What are the responsibilities and job description for the Director of Quality Engineering position at ALKU?
Director of Quality Engineering
Background:
Our client is seeking a Director of Quality Engineering to lead Sustaining Quality and Design Quality for commercialized capital equipment and software/hardware-based medical devices. This leader will oversee post-market quality strategy, design control execution, and manufacturing quality support, ensuring products remain compliant, reliable, and audit-ready throughout the lifecycle.
The role requires strong experience operating within FDA 21 CFR Part 820 and ISO 13485 environments, with deep expertise in design controls, verification & validation, regulatory submissions, and sustaining engineering.
Project:
- Lead quality engineering for sustaining programs across released medical devices.
- Oversee design changes, risk assessments, and change control in compliance with 21 CFR 820, ISO 13485, and ISO 14971.
- Ensure integrity of DHFs, DMRs, DHRs, and risk management files.
- Drive investigations, complaint handling, NCRs, and CAPA to protect product quality and revenue.
- Partner with R&D to translate user needs and design inputs into compliant engineering deliverables.
- Oversee verification, validation, test method validation, equipment qualification, and process validation activities.
- Support 510(k), IDE, and other regulatory submissions related to sustaining changes.
- Lead supplier quality oversight, including qualification and ongoing performance management.
- Represent Quality in cross-functional forums and regulatory inspections.
- Build and develop a high-performing Quality Engineering team.
Required Skills:
- Bachelor’s degree in Engineering or related technical discipline.
- 8 years of experience in medical device quality and product development.
- Strong background in sustaining engineering and design control management.
- Experience supporting manufacturing operations and supplier quality.
- Demonstrated success operating within FDA-regulated and ISO-compliant QMS environments.
- Proven leadership and cross-functional communication skills.
Salary : $170,000 - $200,000