Quality Engineering Manager NeuroPace
Plan, schedule, and complete quality engineering projects in a manner consistent with corporate objectives. Responsible for the successful and timely completion of individual projects as well as the projects of subordinates.
Provide quality engineering leadership and support for electro-mechanical and software product development and design change efforts, in addition to manufacturing and supplier improvement projects, through participation on project teams. Perform the following types of tasks as needed, ensuring compliance with industry standard practices and regulatory requirements:
Participate in development of project schedules, plans, and DHF deliverables, including product requirements and risk management documentation; participate in design verification and validation activities.
Participate in manufacturing process development, manufacturability analyses and transfer to manufacturing, including process validation, tooling and equipment qualifications.
Support new and ongoing process improvements, including manufacturing ramp up activities.
Participate in selection of suppliers and manage the supplier audit process. Work with suppliers to improve their performance by developing relationships and working with suppliers on new development, part issues, corrections, and changes.
Manage the Quality Control personnel and inspection activities by ensuring that appropriate instructions, tools and equipment are provided for inspection activities and QC inspectors' work load is prioritized to meet production schedules. Suggest and implement areas for improvement and increased efficiency as manufacturing volume increases.
Manage the failure analysis and reliability testing laboratory and technicians. Assist with resolution of product and process defects focusing on root cause analysis, risk assessment and implementation of effective corrective action.
Provide supervision and guidance to direct reports and/or junior employees on an ongoing basis, ensuring the highest possible quality principles and practices are embraced.
Additional responsibilities include providing statistical analysis guidance, participating on change control board for design and manufacturing changes and performing trending of key quality system elements; prepare analyses and participate in management reviews.
BS degree in a recognized engineering discipline, preferably Electrical or Mechanical, Engineering.
7 years minimum experience as a quality professional, preferably in a medical device or related industry with demonstrated increase in responsibility including supervision or management experience.
Demonstrated working knowledge of FDA QSR and/or ISO 13485.
Excellent verbal and written skills, interpersonal skills, and demonstrated management and leadership skills.
Demonstrated working knowledge of statistical analysis and risk management practices.
NeuroPace is an equal opportunity employer offering a competitive compensation and benefits package including medical, dental, vision, 401(k), and stock options.
||1375 Shorebird Way |
Mountain View, CA 94043