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SalaryThe Sr. Quality Assurance Engineer is responsible for facilitating/managing Design Assurance and Sustaining Quality Engineering activities in support of the Quality Management System (QMS). The responsible person will also have active participation in CAPA, Risk Management, Deviation, Change Control, and Supplier Management processes.
The Sr. Quality Engineer will assist in the support and oversight of manufacturers and service providers tasked with the performance of critical operations within the Nalu supply chain. Sr. QE must demonstrate effectiveness in task completion, decision-making, and team leadership. A functional understanding of design and manufacturing controls per ISO 13485 Quality Systems and 21 CFR 820 regulations is also required.
Responsibilities:
- Supports new product development and product maintenance through the application of quality engineering disciplines and the use of the Nalu quality system and industry regulations for medical devices.
- Ensures product safety by driving risk management activities including authoring risk management plans, interfacing with Clinical Affairs, and facilitating and mentoring engineers on system risk assessments.
- Provides expertise in statistical analysis for Quality Engineering projects
- Performs / leads root cause analysis on product or contract manufacturer processes to determine corrective action(s), as necessary.
- Supports process validation activities (perform and/or review IQ/OQ/PQ requirements and results).
- Provides internal and external audit support.
Qualifications:
- Education: Bachelor's degree required in science, engineering (electrical, preferred), life sciences, or physical sciences; master’s degree preferred.
- Minimum of 5 years of experience in Quality or related field with FDA Class II or Class III medical devices.
- Quality-focused experience with Class II and/or Class III medical devices, preferably with implantable neurostimulators or active implantable devices.
- Risk Management, CAPA, ISO 14971, Design and Process FMEA
- Statistical techniques and sampling plans, familiarity with Minitab or other statistical analysis software
- FDA medical device labeling (labels, manuals, UDI) experience
