Continuous Improvement Quality Engineer (CIQE)

Intuitive•Sunnyvale, CA

5d•Onsite

About The Position

This role ensures that quality systems, products, and manufacturing processes comply with quality standards by supporting and driving improvements within the organization, adhering to international industry practices and regulations such as ISO 13485 and 21CFR820. The Continuous Improvement Quality Engineer (CIQE) will meet objectives, provide support and expertise in the Non-Conformance (NC) and Corrective and Preventive Action (CAPA) process and system, and implement actions to drive improvement. This individual will partner with subject matter experts on various NC/CAPA activities and support other improvement initiatives. The CIQE will evolve existing processes and systems to ensure timely escalation, identification, and robust investigation of product quality and compliance issues within a closed-loop quality management system.

Requirements

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
Strong verbal/written communication skills with ability to communicate effectively at multiple organizational levels
Multi-tasks, prioritizes, and meets deadlines in a timely manner
Strong interpersonal, organizational, and follow-up skills
Passionate about making products and processes better
Engineering Bachelor’s degree - Preferably in science or healthcare fields.

Nice To Haves

ASQ certification : CQE, CQA
Knowledge of Process improvement tools and methodologies (Lean, Six Sigma) is preferred.
Green or Black Belt Certification in Lean or Six Sigma is a plus
NC or CAPA Review and Approval
Project Management experience
Experience working in a broader enterprise/cross-division business unit model

Responsibilities

Support and comply with Company and Site’s Health, Safety, and Environmental programs and requirements.
Use personal protective equipment (PPE) as applicable.
Use devices, accessories, tools, and equipment according to the process, verifying that they are in good condition for use and reporting those that are in poor condition for repair.
Communicate unsafe acts or conditions to superiors.
Participate in Health, Safety, and Environment courses.
Maintain order and cleanliness in the workstation (5S) under responsibility.
Comply with health regulatory and International Standard (ISO13485) requirements, Company and site policies, operating procedures, processes, and task assignments.
Participate in or lead completion of NC & CAPA projects, assuring compliance, quality, and timeliness of records.
Communicate confidently and effectively with all levels of management, peers, and key stakeholders, including timely escalation of quality issues.
Lead and collaborate with cross-functional teams using various methodologies (e.g., Six Sigma root cause analysis/problem-solving skills).
Independently investigate, gather data, trends, and perform preliminary analysis.
Process requests, ensuring subject matter experts and action item owners are assigned and provide timely responses in alignment with quality goals.
Lead meetings and communications for NC/CAPA updates, information, and concerns.
Assist with metrics and reporting in accordance with established procedures.
Support the team in delivering and overseeing the NC & CAPA training program.
Assist in initiating, processing, 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.