Full-Time

Sr Continuous Improvement Quality Engineer

CAPA Specialist

Posted on 1/16/2025

Intuitive Surgical

Intuitive Surgical

10,001+ employees

Develops robotic surgical systems and services

Biotechnology
Healthcare

Senior

Sunnyvale, CA, USA

Category
QA & Testing
Manual Testing
Quality Assurance
Required Skills
Data Analysis

You match the following Intuitive Surgical's candidate preferences

Employers are more likely to interview you if you match these preferences:

Degree
Experience
Requirements
  • Quality Engineer: Systems, Assurance, or Quality Control – Minimum 5 Years experience
  • Have worked in a regulated manufacturing industry: Medical devices, Pharmaceuticals, Aerospace, Automobile, Food, etc. - Minimum 5 Years
  • Previous CAPA and/or engineering experience and demonstrated use of quality tools/methodologies. - Minimum 5 Years of work experience
  • Detailed knowledge of Quality System Regulations (21CFR820) and ISO 13485. - Minimum 3 Years
  • Ability to work in a highly matrixed and geographically diverse business environment
  • Quality/Compliance focus and attention to detail
  • Critical thinking skills for analyzing risk, use of root cause analysis tools, and technical aptitude to collect and analyze data for determining an improvement strategy
  • Expertise in cGMP and CAPA documentation
  • Computer skills (advanced Microsoft Office Package and statistical/data analysis and report writing skills)
  • Demonstrated impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Ability to leverage and/or engage others to accomplish projects
  • Strong verbal/written communication skills with ability to communicate effectively at multiple organizational levels
  • Multi-tasks, prioritizes. and meets deadlines in a timely manner
  • Strong interpersonal, organizational, and follow-up skills
  • Passionate about making products and processes better
Responsibilities
  • Support and comply with Company and Site’s Health, Safety, and Environmental programs and requirements
  • Complies with health regulatory and International Standard (ISO13485) requirements, Company and site policies, operating procedures, processes, and task assignments
  • Participate in and lead completion of CAPA projects, assuring compliance, quality, and timeliness of records
  • Communicate confidently and effectively with all levels of management, peers, and key stakeholders, including timely escalation of quality issues
  • Lead and collaborate with cross-functional teams using various methodologies (e.g., Six Sigma root cause analysis/problem-solving skills)
  • Independently investigate, gather data, trends, and perform preliminary analysis
  • Process requests, ensuring subject matter experts and action item owners are assigned and provide timely responses in alignment with quality goals
  • Leads meetings and communications for CAPA updates, information, and concerns
  • Responsible for assisting with metrics and reporting in accordance with established procedures
  • Support the team in delivering and overseeing the CAPA training program
  • Assist in initiating, processing, and completing CAPA records in the electronic system
  • Execute and provide on-time completion of Quality Engineering deliverables
  • Provide support and CAPA’s process/system subject matter expertise during audits and inspections
  • Support the review and approval of any documentation required by CAPA deliverables
  • Mentor CAPA teams and colleagues who are beginner-level in CAPA processes and systems
Desired Qualifications
  • ASQ certification : CQE, CQA
  • Knowledge of Process improvement tools and methodologies (Lean, Six Sigma) is preferred. Green or Black Belt Certification in Lean or Six Sigma is a plus
  • CAPA Review and Approval
  • Project Management experience
  • Experience working in a broader enterprise/cross-division business unit model

Intuitive Surgical specializes in robotic-assisted surgery and minimally invasive care. Their main product is a robotic surgical system that enhances the precision of surgical procedures, allowing physicians to perform operations with greater accuracy and less physical strain. This system is designed to be used in hospitals and surgical centers, providing healthcare providers with advanced technology to improve patient outcomes. Unlike many competitors, Intuitive focuses not only on the sale of surgical systems but also on recurring revenue from instruments, accessories, and service contracts, creating a sustainable business model. The company's goal is to expand the use of minimally invasive techniques in surgery, ultimately benefiting patients through improved recovery times and outcomes.

Company Size

10,001+

Company Stage

IPO

Total Funding

$21.4M

Headquarters

Sunnyvale, California

Founded

1995

Simplify Jobs

Simplify's Take

What believers are saying

  • Increasing adoption of AI in robotic surgery enhances precision and outcomes.
  • Growing demand for minimally invasive procedures due to faster recovery times.
  • Expansion in emerging markets, especially Asia-Pacific, driven by healthcare investments.

What critics are saying

  • Emerging competition from PROCEPT BioRobotics could impact market share.
  • Legal challenges in India regarding refurbished medical gear imports.
  • Dependency on external partners like FluoGuide for surgical guidance technology.

What makes Intuitive Surgical unique

  • Pioneer in robotic-assisted surgery with advanced technology for precision and fewer constraints.
  • Strong focus on enhancing physician capabilities through innovative surgical systems.
  • Commitment to improving patient outcomes in minimally invasive care.

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Benefits

Hybrid Work Options

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

3%

2 year growth

3%
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Feb 13th, 2025
Intuitive Surgical Completes Public Offering | Intuitive Surgical

SUNNYVALE, Calif.--(BUSINESS WIRE)--Nov. 5, 2003--Intuitive Surgical, Inc. (Nasdaq:ISRG) today announced that it has completed its public offering of 5,000,000 shares of common stock at a purchase price of $14.50 per share. The net proceeds to the Company were approximately $67.7 million.

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The Economic Times
May 30th, 2024
HC rejects PIL on action against import of pricey refurbished medical gear

Senior counsel Sandeep Sethi, appearing for the NGO, sought returning of these items and further sought a penalty on Intuitive Surgical India Pvt Ltd and Intuitive Surgical, Inc for such illegal imports and for violating the rules and regulations.

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May 14th, 2024
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Medical technology-focused company UFP Technologies announced in Q1 it entered into a supply agreement with its largest customer, Intuitive Surgical, to continue supplying products on a semi-exclusive basis for an initial four-year period.

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Apr 23rd, 2024
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Intuitive Surgical (ISRG) rose on its announcement of launch of a new robotic system.

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Mar 12th, 2024
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MarketBeat
Feb 25th, 2024
OMERS ADMINISTRATION Corp Makes New $3.77 Million Investment in Intuitive Surgical, Inc. (NASDAQ:ISRG)

OMERS ADMINISTRATION Corp makes new $3.77 million investment in Intuitive Surgical, Inc. (NASDAQ:ISRG).

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Deepwater Asset Management LLC invests $10.32 million in Intuitive Surgical, Inc. (NASDAQ:ISRG).

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SUNNYVALE, Calif., Feb. 10, 2020 (GLOBE NEWSWIRE) -- Intuitive (Nasdaq: ISRG), a global technology leader in minimally invasive care and the pioneer of...

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