Amick Brown is seeking an experienced Quality Control Engineer
for our direct client.
Location: Sunnyvale, CA
Duration: 1 Year
Roles and Responsibilities:
- Quality Advocacy and Project Management
- Develop and apply corporate level quality metrics.
- Lead and project manage quality initiatives in one or more of these focus areas:
- Product Quality
- Data Quality
- Process Quality
- Failure Analysis
- Provide quality expertise post market release to the quality engineering support team to analyze the returned product.
- Perform 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.
- Analyze and disposition of discrepant material.
- Support manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containments.
- Support development and execution of process validation and verification test plans, protocols, and reports
- Handle projects of various product and subsystem types (Software, Mechanical Hardware, Camera, Disposable accessories like catheter, etc).
- Development teams to develop measurable goals for quality.
- Ensuring that the essential performance aspects are mitigated in the product quality plans.
- Identify critical elements of designs. Recommend design processes and methods to meet quality goals: DFX, etc.
- Provide guidance to other engineers regarding applicable regulatory and statutory requirements and the applicability of these requirements to the ISI products.
- Plan and creation quality standards, quality control, and quality assurance procedures, sampling plans, test methods, fixtures, and processes for 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.
- Education: Bachelor degree in electrical, mechanical or system engineering, math, or physics. Advanced degree preferred.
- 2+ years of working experience in Quality Engineering, minimum 2 years in medical device design or manufacturing environment.
- Able 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.
- Understands product risk management, experience in generate FMEA and process FMEA.
- Understands Design Controls, Change Controls, Product, and Engineering Processes.
- Proficient with generate and execute 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).
- Understands typical Excel data analysis operations (e.g. Vlookup, Pivot table and pivot chart functions) Able 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).
Amick Brown, LLC is an Information Technology consulting company providing IT staffing and managed solutions. Founded in 2010, we are a certified woman-owned small business headquartered in San Ramon, CA with an additional office in Sacramento, CA. Amick Brown’s experienced IT professionals support customers nationwide in both the commercial and public sectors. We are SBA 8(a) and IS0 9001:2015 certified and are an SAP Services Silver Partner.
Regular full-time employees are eligible for the following Amick Brown provided benefits:
- 401k with company match
- Paid time off
- Sick Leave
- Short-Term Disability
- Life Insurance