Intuitive
Healthcare
ContinuousImprovementQualityEngineer(CIQE)
“Continuous Improvement Quality Engineer (CIQE) at Intuitive. Skills: Quality Assurance, CAPA, Process Improvement, Regulatory Compliance. Ensure quality systems compliance. Support and drive improvements”
What You'll Achieve.
Ensure that quality systems, products, and manufacturing processes comply with quality standards; Meet objectives; Drive improvement in the organization; Timely escalation, identification, and robust investigation of product quality and compliance issues; Timeliness of records for NC & CAPA projects; Timely responses in alignment with quality goals; On-time completion of Quality Engineering deliverables
Industry & Context.
Critical thinking skills for analyzing risk; Root cause analysis tools; Technical aptitude to collect and analyze data for determining an improvement strategy
Proof of vaccination against certain diseases including COVID-19 may be required, U. S. export controls may apply, Arrest and conviction records will be considered
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 compliance
Support and drive improvements
Meet objectives and provide support
Partner with subject matter experts
Evolve existing processes/systems
Support and comply with HSE programs
Maintain order and cleanliness
Comply with regulatory requirements
Participate in NC & CAPA projects
Communicate with management and peers
Lead and collaborate with cross-functional teams
Process requests and assign owners
Lead meetings and communications
Assist with metrics and reporting
Support NC & CAPA training program
and complete NC & CAPA records
Execute Quality Engineering 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 on various NC/CAPA activities; Collaborate with cross-functional teams using various methodologies; Work within a team and as an individual contributor; Leverage and/or engage others to accomplish projects
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
Process & Methodology
Demonstrated impactful project management and leadership skills, Ability to lead multi-departmental project teams, Resolve quality-related issues in a timely and effective manner, Project Management experience
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