Description
MAJOR DUTIES AND RESPONSIBILITIES- Responsible for supporting the complete life cycle of a new/modified product, from concept to design transfer, on-going engineering efforts and production support
- Primary quality resource for dealing supply chain issues for key suppliers
- Fundamental understanding of regulations related to medical device quality specifically ISO 13485, ISO14971, 21 CFR Part 820
- Acts as a primary quality representative on design phase and technical reviews.
- Assists in the creation of product and component specifications and inspection requirements.
- Performs formal risk analysis, develop risk control measures and mitigations, and create FMECA in support of risk management.
- Subject matter expert on biocompatibility, sterilization, and packaging validation requirements.
- Excellent writing skills to generate protocols and test methods.
- Performs and participates in internal, supplier, and external audits as required
- Supports overall production through technical oversight of quality inspectors
- Ability to drive innovative, compliant solutions to complex challenges drawing from a broad knowledge of principles, practices, and procedures.
- Familiarity managing quality systems such as complaints, CAPA, handling non-conforming material, rework, calibration, validation, and supplier quality management.
- Reports observations/problems clearly and concisely, recognizing and highlighting specific deviations and presents possible solutions.
- Develops system level design strategies and may lead design, development, testing & refinement of components and sub-systems.
- Recommends and implements changes in quality system procedures and processes.
- Collaboration with other engineering disciplines to ensure that the device will accomplish the design goals.
- Able to work independently with a minimum of supervision and direction.
Requirements:
- Bachelor's degree in a technical discipline
- 7+ years medical device experience
- Knowledge of ISO 13485 and ISO 14971 requirements
- Ability effectively multitask and prioritize
- Good communication skills, hard worker and self-starter
- Analytical and detail oriented mindset
- Experience with Class III / PMA products highly desired
- Experience and certification in performing audits desired
To find out more about Real please visit www.realstaffing.com