Quality Manager

Quality Manager

At AliveCor, we imagine a healthier world powered by access to personalized intelligent information. Heart disease kills more people than anything else in the western world, including all cancers combined. We're on a mission to be the world’s heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical EKG devices and continues to lead the way in empowering consumers and patients to take care of their heart. Using our FDA-cleared medical-grade hardware and software, hundreds of thousands of users have taken more than 100-million heart health measurements and counting.

AliveCor seeks a Quality Manager to join this exciting start-up that is changing the face of mobile health. In this role, you will drive exceptional product quality, safety, design and reliability.  This important technical position is accountable for supporting new product development and sustaining product line activities and has direct influence on component, assembly, and final product quality.  This individual will interact on a daily basis with R&D, Operations, Regulatory, Clinical, Program Management, Customer Service, and Marketing to drive quality into the product design, advise the team on risks and standards, and communicate quality metrics to continually improve and promote AliveCor’s quality policies and practices at AliveCor and our CMs.

Responsibilities:

• Enhance customer experience:
  • Responsible for ensuring all AliveCor products meet and exceed customer expectations and regulatory requirements
  • Develop and monitor post-market product performance data to drive improvements in product design, usability, and reliability
  • Responsible for ongoing risk management throughout the product’s lifecycle
  • Drive timely investigation and closure of product quality related complaints, CAPAs, Nonconformances, and subsequent activities at AliveCor’s contract manufacturers (CMs)
• Supplier Management:
  • Partner with Operations to monitor and continuously improve supplier performance.
  • Provide effective communication to suppliers regarding objectives, issues, and performance to KPIs
  • Perform/assist robust 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).
• Assist new product development:
  • 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 technical resource for requirements, risk, verification and validation, software, process validation, qualification of new equipment, reliability packaging, usability, etc.
  • Lead cross-functional risk management activities and product robust risk management file.
  • 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
• Drive systemic improvements
  • Participate in and provide data for management review
  • Assist and participate in internal and external audits, including supplier audits
  • Maintain and update quality system procedures
  • Maintain quality records and other controlled documents, internally and with suppliers
  • Promote a culture of quality throughout AliveCor
  • Other Quality duties as assigned

Requirements:

• Bachelor’s to advanced degree in STEM or related discipline
• At least 5-10 years’ experience in quality engineering with medical device and/or other regulated industry, including 2 years recent supervisory experience developing direct reports
• Demonstrated competency of 21 CFR 820, MDD, ISO 13485, ISO 14971, IEC 60601, IEC 62304 standards.
• Exceptional problem-solving skills; able to collect and process technical information, conduct root cause investigations, conduct robust risk assessments, etc.
• Demonstrated ability to communicate complex topics with a variety of audiences, including technical teams, management, auditors, and non-experts in a clear and effective manner
• Must have a positive attitude with excellent communication, negotiation, and interpersonal skills to maintain a team-oriented environment and develop critical relationships with contractor manufacturers and suppliers.
• Ability to travel outside the US (25%)

The Perks:

AliveCor is located in downtown Mountain View, CA. We are close to Caltrain and supply car and bike parking for employees. We strive to make your life outside work as smooth as possible while you're at work, and we offer a long list of benefits to make that happen.

• Competitive salary and competitive stock options
• Flexible and generous vacation policy
• Maternity / Paternity Leave
• 401(k)
• TriNet medical coverage, employee 100% covered for medical, dental and vision
• Mobile reimbursement
• Stocked kitchen + weekly catered lunches

A supportive, collaborative group of people who understand that success depends on the team

AliveCor is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.