SF Bay Area Engineering Jobs and Architecture Jobs

TITLE: Product Quality Engineer

Location: 189 N. Bernardo Avenue, Suite 100, Mountain View, CA 94043; Must be in office two (2) days a week, work from home acceptable three (3) days a week..

Salary: $130,000/yr - $176,000/yr

Job Description: Serve as a Quality Engineering representative on teams engaged in new product development, quality processes improvements, business system implementations or other special projects. Maintain quality of design history file and ensure products are developed in compliance with FDA 21 CFR 820, MDD, ISO 13485, and AliveCor’s Design Controls procedures. Reviews and approves product documentation, drawings, process and design verification/validation protocol and reports. Responsible for ensuring products meet customer expectations, quality goals, and regulatory requirements including FDA Quality System Regulations, ISO 13485, EU MDD/MDR requirements, and Risk Management per ISO 14971. Lead cross-functional risk management activities and develop robust risk management files (DFMEA, PFMEA, Hazard Analysis) in support of validation activities. Lead or participate in risk management activities as required based on input from complaints data, including identification of new failure modes. Collaborate on changes to product and processes; ensure compliance to AliveCor’s Change Control process and provide technical support for assessment and execution of the change(s). Support quality and regulatory reviews, inspections, and audits as required. Maintain and update quality system procedures. Support usability engineering activities. Must be in office two (2) days a week, work from home acceptable three (3) days a week.

Requirements: Master’s degree (or foreign degree equivalent) in engineering (any), clinical sciences, applied sciences, or related field and one (1) year of experience in the job offered or related role.

Experience and/or education must include:

• Implementation and maintenance of quality systems in a regulated environment, including Design Controls and Product Lifecycle;
• Risk management tools and hazard analysis based on ISO 14971;
• Working knowledge of appropriate global medical device regulations, requirements, and standards such as: FDA 21 CFR, 820, ISO13485, IEC62304, IEC60601, IEC62366;
• Communicate with engineering and technical teams to support collection of product information and investigation of product or process issues;
• Supplier quality management; and
• Develop verification and validation documentation in compliance with ISO 13485.

CONTACT: Reference job # 7117186 and send resume to hr@alivecor.com