Intuitive
Healthcare
ContinuousImprovementQualityEngineer(CIQE)
“Continuous Improvement Quality Engineer (CIQE) at Intuitive. Skills: Quality systems, CAPA, Regulatory compliance. Ensure quality systems comply with standards. Support and drive improvements”
What You'll Achieve.
Ensure quality systems, products, and manufacturing processes comply with quality standards; Meet objectives; Drive improvement; Ensure timely escalation, identification, and robust investigation of product quality and compliance issues; Assure compliance, quality, and timeliness of records; Resolve quality-related issues in a timely and effective manner; Meet deadlines in a timely manner
Industry & Context.
Root cause analysis; Problem-solving skills; Analyze risk; Determine improvement strategy
Proof of vaccination against certain diseases including COVID-19 may be required, Subject to U.S. export controls for prospective employees from embargoed countries, Final offers contingent upon obtaining an export license and/or executed TCP
What They're Looking For.
Must Have
Quality Engineer: Systems, Assurance, or Quality Control – Minimum 4 Years experience, 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, Engineering Bachelor’s degree - Preferably in science or healthcare fields.
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 comply with standards
Support and drive improvements
Meet objectives and provide support in CAPA process
Implement actions to drive improvement
Partner with SMEs on NC/CAPA activities
Support other improvement initiatives
Evolve existing processes/systems
Ensure timely escalation of issues
Support and comply with HSE programs
Use PPE as applicable
Verify equipment condition
Report unsafe acts or conditions
Participate in HSE courses
Maintain order and cleanliness
Comply with regulatory requirements
Participate in or lead NC & CAPA projects
and timeliness of records
Communicate effectively with all levels
Lead and collaborate with cross-functional teams
Perform preliminary analysis
Process requests and assign owners
Provide timely responses
Lead meetings and communications for NC/CAPA updates
Assist with metrics and reporting
Support NC & CAPA training program
and complete NC & CAPA records
Execute and provide on-time completion of deliverables
Provide process/system expertise during audits
Support review and approval of documentation
Mentor CAPA teams and colleagues
How You'll Work.
Team & Collaboration
Partner with subject matter experts; Collaborate with cross-functional teams; Work within a team and as an individual contributor; Leverage and/or engage others to accomplish projects; Communicate effectively at multiple organizational levels
Communication Scope
Communicate confidently and effectively; Verbal/written communication skills; Communicate effectively at multiple organizational levels
Process & Methodology
Impactful project management, Lead multi-departmental project teams, Resolve quality-related issues, Project management experience
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