- Being a proponent of Product Quality throughout the organization; including the ability to work pragmatically and cooperatively with leaders throughout the company to deliver high-quality product to market quickly, continuously improve it, and rapidly fix problems.
- Working in close cooperation, with a shared vision, with leadership from Quality Assurance, Supplier Quality, Incoming Quality Control, Business Analytics, and others, and communicating throughout the organization.
- Leading and functionally managing the Quality Engineering group (skills and gap assessment, talent acquisition, and development).
- Organizing sources and internal customers for quality data; identifying ways across the enterprise to close quality loops more quickly. Structuring needed quality metrics to help others measure themselves and assess the cost of quality appropriately. Facilitating the use of good tools and techniques overall.
- Gathering and making available to enterprise customers a routine set of quality data for their weekly use (standard quality reports).
- Owning the Nonconformance and CAPA systems, leading teams that monitor quality data, ensuring that analyses and documentation meet standards.
- Facilitating weekly product quality meetings and driving high performing teams to focus on product quality enhancements.
- Running periodic Quality Data review meetings and cross functionally to address needs.
- Ensuring that risk estimation is done well at all levels of the organization (Risk Assessment, Failure Mode Evaluations, Process Risk Assessments, Health Hazard Analyses).
- Communicating Lessons Learned to design teams, supplier-facing teams, etc.
- Project-managing Continuous Improvement projects.
- Setting data-driven priorities for continuous improvement of ISI products and processes.
- Ensuring quality/reliability/safety is built into ISI designs, while coordinating with Design Engineering, Manufacturing Engineering, and Supplier Quality.
- Ensuring adequate design control throughout the product life cycle and Quality Engineering deliverables are met.
- Ensuring data quality, process quality for anything that affects ISI product or patient outcome, including the improvement of SOPs, DOPs, etc.
- Generating risk assessments for product in the field, including recall assessment (with Regulatory Compliance)
- Supporting deep technical failure analysis, root cause analysis, resolution, and prevention for challenging quality issues.
- Minimum 5+ years' experience in the quality arena with a complex medical device product, or equivalent quality background
- Minimum 3+ years' experience as a manager in the quality arena
- Education: Minimum Engineering or Physics with Masters Degree or equivalent experience
- Minimum 3+ years medical device company experience within engineering or quality (preferably) manufacturing operations, CAPA systems, and risk-based approaches to quality
- Prior experiences in optical/vision components/subassemblies (i.e. endoscopes and vision systems) and the associated capital equipment are preferred.
- Impeccable integrity
- Proven ability to drive and motivate across functional teams
- Engineering or Engineering Management background; proven electromechanical underpinnings preferred
- Ability to communicate easily with stakeholders and develop compelling vision for the QE group, and find win-win agreements with Engineering. Understand ISI's culture of fast innovation and iterative improvement.
- Exceptional analytic skills as proven by track record for analyzing and fixing complex problems in products and processes
- Training or commensurate experience in the science of quality, matched with real-world experience (Lean, Six-Sigma, Deming, Toyota, etc.)
- Proficiency across the Microsoft Office suite of productivity software
- Excellent judgment in the presence of contending priorities and incomplete data; proven ability to make difficult trade-offs
- A passion for finishing the vital thing, efficiently and well; attention to the right details
- A desire to make work fun
-
Quality Engineer
2 weeks ago
JBL Resources Sunnyvale, United StatesOur Client, the pioneer of and global technology leader in robotic-assisted surgery has an opening for a Quality Engineer in Sunnyvale, CA. With a commitment to improving healthcare, our Client stands at the forefront, building leading-edge, integrated systems and software to pro ...
-
Quality Assurance Engineer
4 days ago
Pinnacle Group, Inc. Sunnyvale, United StatesJob Title: QA Engineer (Manual) I · Location: Sunnyvale, CA 94085 (100% onsite) · Duration: 6 months (possible extension) · Description: · This position requires a self-motivated individual with strong manual QA experience. · Requirement: · Ideal candidate will have testing exper ...
-
Quality Engineer
2 weeks ago
MyKelly Santa Clara, United States Full timeKelly Science, Engineering, Technology and Telecom a managed solution provider and business unit of Kelly Services, is currently seeking Design Quality Engineers for a long-term engagement at one of our Global Medical Device Manufacturing clients located in Santa Clara, CA. · Thi ...
-
Quality Engineer
1 day ago
ASQ Silicon Valley Section 0613 Cupertino, United StatesAbout the job · Summary · The Home Team provides the foundation that enables an entire ecosystem of secure and intelligent home connectivity. We are developing technologies and building experiences that revolutionize the way people harmonize with their Homes. The team is seeking ...
-
Product Quality Engineer
1 week ago
META Sunnyvale, United StatesMeta Reality Labs is building tools that help people feel connected, anytime, anywhere. We are looking for a product quality engineer to help us to build next generation Portal products. · Product Quality Engineer Responsibilities · US based owner of Product Quality and Quality ...
-
Quality Assurance Engineer
3 weeks ago
Amazon Lab126 Sunnyvale, United States· The Amazon Lab126 team is looking for a Software Quality Assurance Engineer to drive world class quality in the software platform that makes a one of a kind experience today, and will enable exciting new capabilities tomorrow. · A successful candidate will be obsessed with qu ...
-
Care Quality Engineer
5 hours ago
Apple Sunnyvale, United StatesAppleCare Quality Engineer · Sunnyvale,California,United States · Support and Service · AppleCare Service Quality & Technology is a global organization that is seeking an exceptional quality engineer who will be involved in all aspects of product and service quality for Apples ...
-
Manager Quality Engineering
3 weeks ago
Intuitive Surgical Sunnyvale, CA, United StatesCompany DescriptionAt Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. · As a pioneer and market leader in ...
-
Care Quality Engineer
1 day ago
Apple Sunnyvale, United StatesAppleCare Quality Engineer · Sunnyvale,California,United States · Support and Service · AppleCare Service Quality & Technology is a global organization that is seeking an exceptional quality engineer who will be involved in all aspects of product and service quality for Apples ...
-
Manufacturing Quality Engineer
15 hours ago
Apple Sunnyvale, United StatesManufacturing Quality Engineer - Ink · Sunnyvale,California,United States · Operations and Supply Chain · Imagine what you could do here. At Apple, new ideas have a way of becoming extraordinary products, services, and customer experiences very quickly. Bring passion and dedic ...
-
Manufacturing Quality Engineer
1 day ago
Apple Sunnyvale, United StatesSummary · Posted: May 20, 2024 · Weekly Hours: · 40 · Role Number: · Imagine what you could do here. At Apple, new ideas have a way of becoming extraordinary products, services, and customer experiences very quickly. Bring passion and dedication to your job and there's no te ...
-
Quality Engineer 3
3 weeks ago
Intuitive Sunnyvale, United StatesCompany DescriptionAt Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in ro ...
-
Quality Engineer 3
4 weeks ago
Intuitive Sunnyvale, United StatesCompany DescriptionAt Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in ro ...
-
Senior Quality Engineer
15 hours ago
Walmart Sunnyvale, United StatesWhat you'll do at · Position Summary... · What you'll do... · As part of Walmart's Content-to-Commerce team, you will be building automation tests and doing quality engineering and assurance of highly scalable and reliable web and native mobile applications, APIs and data-pipe ...
-
Senior Quality Engineer
2 weeks ago
EBR Systems, Inc. Sunnyvale, United StatesAs a Senior Quality Engineer, you will lead cross-functional project teams, contribute to product specification development, author documents for design verification and validation, process validations, lot release testing and risk analysis, and much more. · Are you curious, cre ...
-
Quality Engineer 3
5 days ago
Intuitive Sunnyvale, United StatesCompany Description · At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. · As a pioneer and market leade ...
-
Software Quality Engineer
2 weeks ago
Elekta Sunnyvale, United StatesAre you a current Elekta employee? · Please click here to apply through our internal career site Find Jobs - Elekta. · Want to join a team with a mission to improve and save lives? · We continually look for motivated and skilled individuals who are interested in supporting o ...
-
Quality Engineer- Manual
4 days ago
VeeAR Projects Inc. Cupertino, United StatesTitle: QA Engineer (Manual) · Duration: 06+ months contract (Quarterly extension) · Location: Cupertino, CA · Job Description · Conversation Kit is a chat platform. · We work with internal businesses to offer customized chat solutions for their clientele. · We're looking for ...
-
System Quality Assurance Engineer
4 days ago
Centraprise Sunnyvale, United StatesJob title: System QA Engineer · Job Location: Sunnyvale, CA - Onsite · Job Type: Fulltime · Job Description: · Desired Skills: Python | Unix | Unix Shell Scripting · Objective · • Create new command line, OS and web software tools for restore, kickoff, status, triage and reportin ...
-
Quality Engineer
15 hours ago
Johnson and Johnson Santa Clara, United StatesRobotics & Digital Solutions, part of the Johnson & Johnson family of companies, is recruiting for a · Quality Engineer , located in · Santa Clara, CA · At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world wh ...
Manager Quality Engineering - Sunnyvale, United States - Intuitive
Description
Company DescriptionAt Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
Job Description
Primary Function of Position:
This person leads and functionally manages the Quality Engineering group. You will interface with leaders including VPs and Directors throughout the design, operations, regulatory, IT, marketing and service areas of Intuitive Surgical. Quality Engineering is primarily responsible for measuring quality and helping the company apply those data quickly, intelligently and consistently. Quality Engineering is broadly responsible for or a stake-holder in Product Quality; Data Quality; Process Quality; Corrective Action Preventive Action (CAPA); Lessons Learned; Solutions to challenging quality problems; Design for Quality in new product; Organizational input to our Quality Review Board; Organization of Enterprise data for quality; Functional specification of Quality enterprise software.
Roles & Responsibilities:
Skills, Experience, Education, & Training:
Must Have
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.