Continuous Improvement Quality Engineer (CIQE)

Regulatory Jobs; Peachtree Corners (GA); On-site; USD 90,000 - 120,000; Full time

Job summary

Intuitive Surgical is seeking a Quality Engineer to support NC/CAPA activities, investigate quality issues, and drive continuous improvement within a regulated manufacturing environment.

The role requires working with cross-functional teams to ensure compliance with ISO 13485 and 21 CFR 820, and to assist with audits and process improvements across the site in Peachtree Corners, GA.

Qualifications

• Bachelor's degree in engineering or related field.
• 4+ years in quality engineering within regulated manufacturing.
• Experience with NC/CAPA and quality tools.
• Knowledge of 21 CFR 820 and ISO 13485.

Responsibilities

• Support NC/CAPA activities to ensure timely resolution and documentation.
• Investigate quality issues and perform data analysis for root cause identification.
• Lead cross-functional teams in problem-solving and project execution.
• Assist in audits/inspections and maintenance of quality systems.

Skills

Quality Systems

CAPA

21 CFR 820

ISO 13485

Root Cause Analysis

Six Sigma

Project Leadership

MS Office

Data Analysis

Education

Engineering Bachelor's degree

Tools

MS Office

Statistical software

Job description

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.

We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.

Primary Function of the Position

Ensure that quality systems, products, and manufacturing processes comply with quality standards by supporting and driving improvements in the organization and in accordance with international industry practices and regulations (e.g., ISO 13485, 21CFR820). Meet objectives, provide support and expertise in NC & corrective and preventive action (CAPA) process and system and implementing actions to drive the improvement. S/he will partner with subject matter experts on various NC/CAPA activities in addition to supporting other improvement initiatives. S/he will evolve existing processes/systems to ensure timely escalation, identification, and robust investigation of product quality and compliance issues within a closed-loop quality management system.

Essential Job Duties

• Support and comply with Company and Site’s Health, Safety, and Environmental programs and requirements, including:
• Use of personal protective equipment (PPE) as applicable.
• Use devices, accessories, tools, and equipment according to the process, verifying that they are in good condition for use and reporting those that are in poor condition for repair.
• Communicates unsafe acts or conditions to their superiors.
• Participates in the Health, Safety, and Environment courses established.
• Maintains order and cleanliness in the workstation (5S) under responsibility.
• Complies with health regulatory and International Standard (ISO13485) requirements, Company and site policies, operating procedures, processes, and task assignments.
• Participate in or lead completion of NC & 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 NC/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 NC & CAPA training program.
• Assist in initiating, processing, and completing NC & CAPA records in the electronic system.
• Execute and provide on-time completion of Quality Engineering deliverables.
• Provide support and NC’s or CAPA’s process/system subject matter expertise during audits and inspections.
• Support the review and approval of any documentation required by NC/CAPA deliverables.
• Mentor CAPA teams and colleagues who are beginner-level in NC/CAPA processes and systems.

Required Skills and Experience

• Quality Engineer: Systems, Assurance, or Quality Control – Minimum 4 Years experience
• Have worked in a regulated manufacturing industry: Medical devices, Pharmaceuticals, Aerospace, Automobile, Food, etc. - Minimum 4 Years
• Previous NC & CAPA and/or engineering experience and demonstrated use of quality tools/methodologies. - Minimum 4 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 NC/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

Required Education and Training

• Engineering Bachelor’s degree - Preferably in science or healthcare fields.

Working Conditions

• Desk and meeting rooms

Preferred Skills and Experience

• 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
• NC or CAPA Review and Approval Project Management experience
• Experience working in a broader enterprise/cross-division business unit model

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 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.

U.S. Export Controls Disclaimer:In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process).

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’sstart date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.

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.

This position may be filled at a different job level than listed here depending
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.

Accommodation & Accessibility Notice:

Intuitive is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require assistance or an accommodation during any part of the application or interview process, please contact People Services at [e-mail].

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 compensation ranges are listed.