SF Bay Area Computer Jobs and IT Jobs

TITLE: Senior Quality Engineer

Location: 189 N. Bernardo Avenue, Suite 100, Mountain View, CA 94043; Must be available to work in office 3 days per week. Work from home is acceptable 2 days a week.

Salary: $165,000 /yr - $190,000 /yr

Job Description: Ensure AliveCor products perform as intended and meet/exceed customer expectations. Work closely with Regulatory, Engineering, Product Management, Operations, Clinical, and the Customer Service team to implement and maintain an ISO 13485 and FDA compliant Quality Management System. Work closely with AliveCor’s suppliers to continually improve the quality of AliveCor products. Represent Quality on new product development programs with key responsibility as being an internal advocate for exceptional customer experience through product quality, safety, design, and reliability. Serve as a technical resource for requirements, risk, verification and validation, software, process validation, qualification of new equipment, reliability packaging, usability. Lead cross-functional risk management activities and develop robust risk management files. 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. Support regulatory submissions. Provide input to customer guides, online FAQs, etc. to improve customer experience. Partner with Operations to monitor and continuously improve supplier performance. Provide effective communication to suppliers regarding objectives, issues, and performance to KPIs. Assist with device failure analysis and returned device investigations. Perform/assist root cause investigations for issues and drive corrective actions, using appropriate failure analysis and statistical methods. 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). Lead or participate in risk management activities as required based on input from complaints data, including identification of new failure modes. Evaluate and approve design changes, manufacturing process changes, and supplier changes to ensure that they meet quality and regulatory standards. Initiate and execute CAPAs or NCs as needed. Support quality and regulatory reviews, inspections, and audits as required. Maintain and update quality system procedures, quality records, and other controlled documents, internally and with suppliers. Must be available to work in office 3 days per week. Work from home is acceptable 2 days a week.

Requirements: Bachelor’s degree or foreign degree equivalent in Engineering, Clinical Sciences, or related field and five (5) years of progressive, post-baccalaureate experience in the job offered or related role in the medical device or other medically regulated field. Alternatively, company will accept a master’s degree or foreign degree equivalent in Engineering, Clinical Sciences, or related field and two (2) years of experience in the job offered or related role in the medical device or other medically regulated field. Any suitable combination of education, training, or experience is acceptable.

Experience and/or education must include:

1. Working knowledge of appropriate global medical device regulations, requirements, and standards including: FDA 21 CFR Parts 803, 806 and 820, ISO13485, ISO14971, IEC62304, IEC60601, IEC62366;

1. Design and development of activities pertaining to electro-mechanical devices, and knowledge of the relevant design control regulations and standards;
2. Conducting Failure Mode and Effects Analysis (FMEA) or Hazard Analysis for product design and production processes, and using appropriate failure analysis and statistical methods to drive root cause analysis (RCA) and corrective action plan (CAPA) implementation; and
3. Developing and implementing verification and validation activities for products and critical components testing with suppliers, using various standards (ASTM, MIL-STD, IEC, UL) and custom tests, and planning, executing, and reviewing critical components test plans with suppliers.

CONTACT: Reference job #6879336 and send resume to hr@alivecor.com.