Intuitive

Healthcare

ContinuousImprovementQualityEngineer(CIQE)

Sunnyvale, California, United States FULL TIME
The Brief

“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.

Healthcare
Problems you'll solve

Root cause analysis; Problem-solving skills; Analyze risk; Determine improvement strategy

Eligibility Requirements

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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