Intuitive

Healthcare

ContinuousImprovementQualityEngineer(CIQE)

Sunnyvale, California, United States FULL TIME
The Brief

“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.

Healthcare
Problems you'll solve

Critical thinking skills for analyzing risk; Root cause analysis tools; Technical aptitude to collect and analyze data for determining an improvement strategy

Eligibility Requirements

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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