Intuitive
healthcare
ContinuousImprovementQualityEngineer(CIQE)
“Continuous Improvement Quality Engineer (CIQE) at Intuitive. Skills: Continuous Improvement, Quality Engineering, NC & CAPA, Regulatory Compliance (ISO 13485, 21CFR820). Ensure quality systems, products, and manufacturing processes comply with quality standards. Support and drive improvements in the organization”
What You'll Achieve.
Meet objectives; Drive improvement; Ensure timely escalation, identification, and robust investigation of product quality and compliance issues; Assure compliance, quality, and timeliness of records for NC & CAPA projects; Provide timely responses in alignment with quality goals; Execute and provide on-time completion of Quality Engineering deliverables
Industry & Context.
Critical thinking skills for analyzing risk; Root cause analysis; Problem-solving skills
Use of personal protective equipment (PPE) as applicable, Verify devices, accessories, tools, and equipment are in good condition for use and report those in poor condition, Communicates unsafe acts or conditions to superiors, Participates in Health, Safety, and Environment courses, Maintains order and cleanliness in the workstation (5S), Proof of vaccination against certain diseases including COVID-19 may be required, Subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status
What They're Looking For.
Must Have
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, verbal/written communication skills with ability to communicate effectively at multiple organizational levels, Multi-tasks, prioritizes. and meets deadlines in a timely manner, interpersonal, organizational, and follow-up skills, Passion for making products and processes better
Nice to Have
ASQ certification: CQE, CQA, Knowledge of Process improvement tools and methodologies (Lean, Six Sigma), Green or Black Belt Certification in Lean or Six Sigma, NC or CAPA Review and Approval, Project Management experience, Experience working in a broader enterprise/cross-division business unit model
What You'll Do.
Ensure quality systems
and manufacturing processes comply with quality standards
Support and drive improvements in the organization
Support and drive improvements in accordance with international industry practices and regulations (e.g.
provide support and expertise in NC & corrective and preventive action (CAPA) process and system
Implement actions to drive improvement
Partner with subject matter experts on various NC/CAPA activities
Support other improvement initiatives
Evolve existing processes/systems to ensure timely escalation
and robust investigation of product quality and compliance issues within a closed-loop quality management system
Support and comply with Company and Site’s Health
and Environmental programs and requirements
Participate in or lead completion of NC & CAPA projects
and timeliness of records
Independently investigate
and perform preliminary analysis
ensuring subject matter experts and action item owners are assigned and provide timely responses in alignment with quality goals
Assist with metrics and reporting in accordance with established procedures
Support the team in delivering and overseeing the NC & CAPA training program
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
How You'll Work.
Team & Collaboration
Partner with subject matter experts on various NC/CAPA activities; Collaborate with cross-functional teams using various methodologies; Communicate confidently and effectively with all levels of management, peers, and key stakeholders; Lead meetings and communications for NC/CAPA updates, information, and concerns; Ability to work within a team and as an individual contributor; Ability to leverage and/or engage others to accomplish projects; Mentor CAPA teams and colleagues
Communication Scope
Communicate confidently and effectively with all levels of management, peers, and key stakeholders; verbal/written communication skills with ability to communicate effectively at multiple organizational levels; Leads meetings and communications for NC/CAPA updates, information, and concerns
Process & Methodology
Demonstrated impactful project management and leadership skills, Ability to lead multi-departmental project teams, Ability to resolve quality-related issues in a timely and effective manner, Project Management experience (preferred)
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