Summary: Silk Road Medical is looking for a versatile Quality Specialist with a specific interest in GMP compliance for medical device products. The Quality specialist role is a diverse role with in our Quality team and is responsible for quality system documentation and quality control inspections.
We are looking for someone with an eye for detail and the ability to juggle multiple tasks and projects across the organization in a thorough and systematic way. You must be comfortable working independently within your own areas of responsibility and also be an excellent team player with a positive attitude and committed approach to quality management. You have excellent communication skills at all levels and the desire to work in a rapidly growing environment.
- Experience with both paper and electronic Document Control Systems.
- Perform various quality assurance tasks such as review of quality records, including lot history records, sterilization records and returned material records.
- Create and update quality system documents such as policies and standard operating procedures.
- Maintenance of Device History Records as required.
- Tracks and reports on quality and business measurements such as complaints, in-process defects, field failures and non-conforming materials.
- Coordinate the reporting, analysis, and resolution of material nonconformance incidences.
- Participate in Material Review Board meetings.
Product Testing Support
- Provides input and support for product testing throughout the lifetime of the product (prototypes, DV&V, post-production, etc.).
Quality Inspection Support
- Performs visual and dimensional inspections and evaluations of components and devices according to individual product specifications.
- Complete First Article Inspections including supporting documentation.
- Experience utilizing basic measuring devices (calipers, micrometers, pin gauges, optical comparator) to perform complex inspections of machined parts.
- Experience performing measurements in a Controlled Environment Room and performing measurements under a microscope.
- Maintains accurate and up to date records of all materials. These activities may be conducted during incoming receiving, in-line inspections, returned materials, etc.
- Assist in the development and improvement of product assurance systems such as receiving quality assurance, in-process quality assurance, statistical process control, non-conforming materials, product lot release testing and finished goods control.
- Qualify and monitor suppliers and service providers
- Maintain supplier files and approved supplier list.
Experience, Knowledge and Skills Required:
- 5-8 years of work experience in the medical device industry.
- Experience with FDA requirements, knowledge of regulations such as GLP, GMP, ISO 13485 and other international regulatory requirements.
- Proficient computer skills (MS Office).
- Good verbal and written communication skills. Must be detail oriented and able to work independently.
Interested candidates should submit their resume to firstname.lastname@example.org.