Description
GENERAL DESCRIPTION:This position, reporting to the Director of QA, has responsibilities in the following areas: Design Control support, Verification and Validation, Statistical Process Control, Product Control, including protocols and procedures, Complaint Analysis, and participates in Material Review Board. Administer CAPA Program, perform audits, disposition non-conforming product and create supporting documentation. The position will work with both R&D and Production to support the development, transfer, maintenance, and improvement of production processes for products in accordance with the company's Quality Systems and customer contracts. This position has direct responsibility for improving process control, product quality and reduction of production costs.
FUNCTIONS:
1. Design Control: In conjunction with Research and Development staff assist with creation of documentation supporting design of new products and/or product enhancements. Facilitate hazards identification process. Create and maintain FMEAs, FTAs and other elements of risk analyses. Create design and process validation and verification protocols. Create sterilization, packaging and sealing protocols. Create test reports. Provide documentation as required to support regulatory submissions. Represent QA in product development core teams.
2. Process Development: Support efforts for developing or improving process capabilities, improving product manufacturability, and reducing scrap and production costs. Create production fixturing IQs and OQs. Create and review process and IQC inspection documentation. Create and validate standard test methods. Interface with Development Engineering in the transfer and qualification of products and processes. Develop and implement QC processes compatible with continuous flow manufacturing processes. Develop, implement and monitor Statistical Process Control charts.
3. Compliance: Perform engineering testing and validation. Analyze product complaints and create complaint analysis reports. Create associated documentation in accordance with domestic and international regulatory requirements. Utilize statistical methods to analyze test data and present data in investigative reports. Perform cross-functional departmental audits and Supplier Quality audits.
4. CAPA Program: Administer CAPA program to ensure timely closure in accordance with corporate goals. Create CAPA documentation including corrective and preventive action plans, and follow up reports. Disposition NCMRs and create supporting documentation including rationales and justifications.
5. Training: Train Assemblers, technicians or engineers on test methods and documentation for existing product and new product being transferred into manufacturing.
6. Other duties as assigned
Requirements:
* BS in Engineering or related discipline or equivalent experience
* Min 4 years medical device (preferred) or biotech experience
* FDA QSR and ISO 13485 compliance experience required
* Strong understanding of Design Control and Product Development Processes required
* Validations experience required
* Solid working knowledge of statistics required
* Basic understanding of statistical process control (SPC) required
* Strong understanding of metrology preferred
* Test method validation experience preferred
* Lean Manufacturing experience preferred
* Project Management/Planning experience preferred
* Excellent communications skills (both written and verbal) required
* Strong basic computer skills (MS Word, Excel) required
* Familiarity with SolidWorks, statistical software desired
* ASQC QE certification preferred
* 6-sigma training desired
* Ability to work independently or in team setting
* Must be able to travel occasionally
To find out more about Real please visit www.realstaffing.com