Quality Assurance Engineering Manager, Sustaining HW/SW
2 weeks ago
Daily Responsibilities:
- Lead and mentor Quality Engineers and Technicians.
- Oversee Quality Transfer and Design Control to manufacturing making sure process is scalable
- Monitor field issues of product and resolve with through collaboration with suppliers
- Ensure compliance with regulations and industry standards.
- Oversee daily quality activities and maintain budget.
- Support manufacturing and operations, both internally and with external vendors.
- Drive process improvements and participate in supplier quality activities.
- Manage design control, risk management, and compliance for sustaining projects.
- Conduct hardware and software verification and validation.
- Audit Design History Files (DHFs) for compliance.
- Investigate and document results for returned devices and complaints.
- Maintain the Servicing Program and support distribution quality activities.
- Analyze quality metrics and initiate Document Change Orders (DCOs).
- Participate in audits and support regulatory submissions.
Qualifications:
- Education: Bachelor’s in Electrical/Software Engineering (Master’s preferred).
- Experience: 10+ years in Hardware and Embedded Software Design, with 8+ years in the Medical Device industry.
- Technical Skills:
- Analog and Digital Circuit Design, PCB Layout, and prototype development.
- Embedded systems, version control, issue tracking, and control electronics for medical devices.
- Management: 2+ years managing others or equivalent experience.
- Regulations: Knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 60601, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, and MDSAP.
- Statistical Analysis: Proficient with Minitab and statistical techniques.
- Preferred Experience: Class III medical devices and electromechanical products, complaint investigations.
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