Principal Quality Engineering Manager, Quality, Quality and Lean
Amazon Lab126 is an inventive research and development company that designs and engineers high-profile devices like Kindles, Echos, Fire Tablets, Fire TVs and the all new Astro household robot. Lab126 began in 2004 as a subsidiary of Amazon.com, Inc. Since then, we have worked to build products with breakthrough hardware technology as well as revolutionizing things like reading, watching TV and home security. What will you help us create?
The Operations and Supply Chain group is looking for an individual who wants to work on a rapidly growing Medical Products business. We are a critical part of the hardware development process. We ensure successful delivery of product launches and ongoing support, grow the capabilities of our current systems to meet our customer's needs, and drive continuous improvement for the company.
This role is available in either Sunnyvale, CA or San Diego, CA
Key job responsibilities
The Principal Quality Engineering Manager (QEM) is responsible for ensuring that our products are designed for quality and adhere to all applicable medical and regulatory requirements, including FDA 21 CFR 820, ISO 13485 and ISO 14971. As early as the concept phase of the product, the Principal QEM will develop a risk assessment utilizing the NUDD process (New, Unique, Different, Difficult). This risk assessment will be comprehensive of lessons learned on previous products, along with technological, manufacturing and operational risks to the current design. The Principal QEM will be responsible for identifying these risks and working with the appropriate product development functions to ensure the critical and high risk items are prevented prior to validating the final design.
The Principal QEM will also own quality in the sustaining phase of the product. The successful candidate will establish quality goals and monitor performance, investigate the full suite of failure analysis leading to root cause determination and subsequent closed loop corrective action. Leads quality lessons learned and institutes remedies to prevent re-occurrence of quality issues and possess a high sense of urgency when managing critical issues.
In addition to the work done in the New Product Introduction (NPI) and Sustaining phases, the Principal QEM of Medical Products will drive continuous improvement in all aspects of the job, be able to deal with ambiguity, and influence at all levels of the company.
A day in the life
The Principal Quality Engineering Manager for Medical Products will:
- Be the lead reviewer managing a process of root cause corrective action on large/business impacting quality issues during all phases of the product lifecycle.
- Understand the technology and functionality of consumer electronic products, and be able to assess the risk to a negative customer experience, so that it can be prevented during development.
- Be an expert in advanced quality methods and protocol.
- Lead cross-functional teams in Design for Quality initiatives.
- Utilize your comprehensive knowledge of standards, related disciplines, company strategy and goals, to ensure a positive customer experience.
- Deliver solutions to complex problems through in-depth data analysis and forensics by using methodical approaches, along with experience, innovation and judgment to make decisions that may be based on partial information.
- Understand detailed implications of decisions and recommendations and be able to communicate recommended solutions to the product development team, all the way up through the executive leadership of the company.
- Align cross-functionally, influencing a broad spectrum of stakeholders to deliver on the quality policy.
- Create standards around which others will operate and build consensus
- Determine specific quality related functional milestones during NPI
- Some international travel will be required
- BSME/BSIE/BSEE or related Engineering degree
- 12+ years in an engineering and/or quality role
- Experience using Jmp, Minitab or other statistical tools
- Understanding of HW technology at the system and commodity level
- Understanding of SW usability
- Detailed understanding of FDA 21 CFR 820, ISO 13485 and ISO 14971
- Prior experience bringing new Medical Products to mass production
- Advanced degrees in Operations Management, Mathematics/Engineering, or an MBA with a quantitative focus
- Proven ability to influence others, facilitate agreement among stakeholders with different interests
- Excellent written and verbal communication skills, building relationships
- Technical aptitude and familiarity with the design and utilization of complex systems
- Proven track record of complex and creative problem solving and the desire to create and build new processes
- Advanced knowledge of SQL, Excel, and Access
- Data mining and statistical analysis skills with experience with creating and using data repositories
- Excellent business judgment, strong written and oral communication skills, and a practical, common sense approach to getting things done
Amazon is committed to a diverse and inclusive workplace. Amazon is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. For individuals with disabilities who would like to request an accommodation, please visit https://www.amazon.jobs/en/disability/us.