Full-Time

Copy of Sr Continuous Improvement Quality Engineer

CAPA Specialist

Posted on 1/16/2025

Intuitive Surgical

Intuitive Surgical

5,001-10,000 employees

Develops robotic surgical systems and services

Biotechnology
Healthcare

Senior

Norcross, GA, 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. The company develops and manufactures robotic surgical systems that enhance the precision of surgical procedures, allowing physicians to operate with greater accuracy and fewer limitations. Their products include advanced robotic systems, along with instruments and accessories that are essential for these surgeries. Unlike many competitors, Intuitive focuses not only on the sale of surgical systems but also on providing ongoing support through service contracts and the sale of related accessories, creating a recurring revenue model. The primary goal of Intuitive Surgical is to improve patient outcomes by expanding the capabilities of minimally invasive surgical techniques.

Company Size

5,001-10,000

Company Stage

IPO

Total Funding

N/A

Headquarters

Sunnyvale, California

Founded

1995

Simplify Jobs

Simplify's Take

What believers are saying

  • Increasing demand for robotic-assisted surgery in Asia-Pacific drives growth opportunities.
  • Integration of AI enhances precision and outcomes in Intuitive's surgical robotics.
  • Trend towards outpatient surgeries boosts demand for minimally invasive systems.

What critics are saying

  • Increased competition from emerging companies like PROCEPT BioRobotics.
  • Legal challenges related to import of refurbished medical gear may affect reputation.
  • Dependence on key suppliers like UFP Technologies poses supply chain risks.

What makes Intuitive Surgical unique

  • Pioneer in robotic-assisted surgery with advanced technology for precision and fewer constraints.
  • Strong focus on minimally invasive care, enhancing physician capabilities and patient outcomes.
  • Global leader with a comprehensive range of surgical systems and related services.

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Benefits

Hybrid Work Options

Company News

The Economic Times
Sep 26th, 2024
Intuitive Surgical opens GCC in Bengaluru, to hire 250 people

Intuitive Surgical, a global major in robotic-assisted surgery (RAS) technology, announced the opening of its Global Capability Centre (GCC) in Bengaluru on Thursday.

MarketBeat
Aug 14th, 2024
Is PROCEPT BioRobotics the Next Big Thing in Surgical Robotics?

PROCEPT BioRobotics operates in the medical sector and competes with medical robot and device makers like Intuitive Surgical, Medtronic PLC NYSE: MDT, and Zimmer Biomet Holdings NYSE: ZBH.

EIN News
Jun 28th, 2024
Hepato-Pancreatico-Biliary (HPB) Surgical Device Market Size, Share, Revenue, Trends And Drivers For 2024-2033

For instance, Intuitive Surgical Inc. launched SureForm, a robotic-assisted surgical stapler with SmartFire technology, enhancing surgical precision across various tissue types.

Yahoo Finance
Jun 5th, 2024
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In a public-private collaboration, Intuitive worked with the FDA, healthcare analytics company Aetion, and the National Evaluation System for health Technology (NEST), utilizing its NEST Mark process to support the validity of the real-world data used in the labeling revision submission.

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.

Insider Monkey
May 14th, 2024
UFP Technologies' (UFPT) Shares Rose Following an Agreement With Intuitive Surgical

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.

Insider Monkey
Apr 23rd, 2024
Intuitive Surgical (ISRG) Rose on its Announcement of Launch of a New Robotic System

Intuitive Surgical (ISRG) rose on its announcement of launch of a new robotic system.

Aunt Minnie Europe
Mar 12th, 2024
FluoGuide to collaborate with Intuitive Surgical

FluoGuide is collaborating with Intuitive Surgical to advance the clinical development of FG001 for robotic surgical guidance of brain cancer surgery, head and neck cancer surgery, and photothermal therapy for brain cancer treatment.

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).

Slater Sentinel
Jan 8th, 2024
Deepwater Asset Management LLC Invests $10.32 Million in Intuitive Surgical, Inc. (NASDAQ:ISRG)

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

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Aug 17th, 2023
MENDAERA ANNOUNCES EXPANSION INTO PRODUCTION FACILITY

San Mateo, CA – August 17, 2023 – Mendaera, an innovator in healthcare robotics, today announced its expansion into a production facility to support future growth and operations. The company has completed research and design of its collaborative robotic system, and is now focused on completing development and obtaining FDA clearance. The new Silicon Valley facility will enable rapid growth of the organization, as well as volume manufacturing for product launch. Mendaera is developing technology

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Sep 15th, 2022
Galvanize Therapeutics Pulls In $100M Series B

SAN CARLOS, CA, Galvanize Therapeutics today announced it has completed a $100 million Series B funding round.

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Sep 24th, 2020
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Analytics India Magazine
Jul 20th, 2020
How Are Robots Doing The Colorectal Surgeries In Apollo Hospitals Chennai?

While robotic surgeries offer precise and accurate results, the cost associated has always been a barrier for it to be widely accepted. But, Apollo Hospitals Chennai is one such healthcare provider that has reduced the cost per procedure of robotic colorectal surgeries, making it similar to the cost of a laparoscopic procedure. Recognised as the…

GeekWire
Jun 17th, 2020
The next X-ray? Seattle startup Proprio raises $23M to build high-tech surgical navigation system

Seattle startup Proprio has raised more cash to help build out its surgical technology that some investors believe will be just as transformative as the X-ray.

GlobeNewswire
Feb 10th, 2020
Intuitive Acquires Orpheus Medical to Expand Informatics Platform for Hospitals

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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