Quality Engineer
Job Description
Major Responsibilities
- Identify and prepare quality program requirements for product development and manufacturing products.
- Working understanding of medical design controls and regulatory requirements.
- Provide support and expertise in the implementation and enforcement of ISO9000, EN46001, MDD, QSR requirements, and any other applicable standards.
- Develop/review/execute design verification (including biocompatibility, sterilization and package testing) per appropriate ISO/EN/ANSI standards
- Develop/monitor the effectiveness of the Quality system to identify, bracket, correct, and prevent defects.
- Provide support and expertise in DOE, reliability strategy, and analytical problem solving techniques.
- Create/review qualification/validation documents for conformance to business practices.
- Support ongoing product development and manufacturing.
- Maintain and develop adequate sampling plans, inspection procedures, and test methods.
- Access and support suppliers.
- Performs other related duties as assigned.
Job Requirements
Job Experience
- Minimum of five years related work experience in a medical device or a regulated environment
- Experienced in quality systems (ISO9000 and/or QSR)
- Experience with SPC, Process capability, DOE, GR&R’s, FMEA’s, Sampling Plans, Test Methods and Design verification (A Must)
Education
- 4 years technical degree, or equivalent experience
- CQE, CQA (ratings), preferred
Resumes
Please email resumes to: lrounds@MedVenture.com