Primary Function of Position:
This position has responsibility and authority for:
- New Product Development and Sustaining/Manufacturing Support
- Handle projects of various product and subsystem/component types (electrical, mechanical, optical, etc).
- Develop measurable goals for quality.
- Lead Quality Table meetings.
- Ensuring that the essential performance aspects are mitigated in the product quality plans.
- Provide guidance to other engineers regarding applicable regulatory and statutory requirements and the applicability of these requirements to the ISI products.
- Plan and create quality standards, quality control, and quality assurance procedures, plans, test methods, fixtures, and processes for incoming materials and finished devices.
- Ensure process compliance through the design and development of comprehensive procedures including work instructions, flowcharts, forms, templates, checklists, and other product or process related documentation, for recording, evaluating, and reporting quality data.
- Analyze and disposition of discrepant material.
- Support manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, inspection method qualification, and defect containments.
- Support development and execution of process validation and verification test plans, protocols, and reports.
- Support development and execution of manufacturing line qualification plans, protocols, and reports. Support and drive SMVP/R projects.
- Failure Analysis
- Provide quality expertise to the quality engineering support team to analyze the product failure.
- Perform deep technical failure analysis based on the physics of failure.
- Review and interpret complex data analysis rooted in an understanding of our product hardware and software, the physics of failure, and the use conditions in the clinical / operating room environment.
- Quality Advocacy and Project Management
- Create, process and review various types of Quality Notifications and Change Orders.
- Apply corporate level quality metrics. Lead quality meetings e.g. QDR (Quality Data Review).
- Lead and project manage quality initiatives in one or more of these focus areas: Product Quality, Data Quality and Process Quality.
- Perform mock audits and Gemba walks to ensure compliance with ISI QMS.
- Any other Quality Engineering related function/responsibility as directed by the manager.
Required Knowledge, Skills, and Experience
In order to adequately perform the responsibilities of this position the individual must possess:
- Education: Bachelor degree in electrical, mechanical or system engineering, math, or physics. Advanced degree preferred.
- Experience: 5+ years of working experience in Quality Engineering, minimum 3 years in medical device design or manufacturing environment.
- Language: Fluent in both English and local language.
- Capable to navigate quality and compliance system with minimal oversight on individual projects.
- Demonstrated understanding of CFR 21 820 / ISO 13485 requirements for making process or design changes as well as MDSAP and MDR requirements for supporting internal and external audits.
- Knowledge in product risk management, experience in generating FMEA and process FMEA.
- Knowledge in Design Controls, Change Controls, Product, and Engineering Processes.
- Proficient with generating and executing Qualification and Validation protocol and Quality Assurance Procedures.
- Experienced in leading product containment and rework activities.
- Proficient in SPC & Six Sigma methodology and tools (e.g. uses DMAIC process and basic tools such as 5 Why's, control charts, fishbone diagram).
- Knowledge in typical Excel data analysis operations (e.g. Vlookup, Pivot table and pivot chart functions). Capable to create Multi-source report, trends, and interprets data with minimal oversight.
- Capable of thinking independently and make decision based on limited information.
- Capable of initiating improvement discussion and lead the team toward the goal.
- Can present information in various forms and forums, collaborates with peers across functions. Experience in presenting to cross functional mgmt. communications. (e.g. report writing, presentations, QRB presenter).
- Excellent creative problem-solving skills.
- Excellent communication and documentation skills.
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
