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Quality Assurance Engineer Generic Medical Devices
THIS JOB HAS EXPIRED
General Description:The Quality Assurance Engineer is responsible for quality oversight. The Quality Assurance Engineer will be responsible for the quality function for manufacturing and design process and is responsible for cross functional oversight and reporting between Product Development, Operations and Regulatory. Must be comfortable working in cross functional teams and presenting information to Senior Management, Engineering, Operations and Regulatory.
Key Duties And Responsibilites:
- Evaluates, revises and applies Procedures and Methods related to the GMD Quality Management System
- Ensures compliance of GMD products and processes
- Maintains a working relationship with key supply chain customers
- Ensures GMD and supplier products meet applicable standards and specifications
- Provides guidance and assistance to GMD engineering and product management leadership regarding product and process quality requirements
- Provides guidance and assistance to GMD material and supply leadership during the requirement flowdown, evaluation, selection and monitoring of suppliers
- Administers material review activities on GMD and /or supplier products
- Administers an effective vendor evaluation and audit program for GMD or its supply base to ensure conformance to GMD contract manufactering process and product requirements
- Evaluates GMD or supplier products and processes. Analyzes root causes of deficiencies and ensures proper corrective actions are implemented in a timely manner. Participates in cross-functional team efforts to improve GMD or supplier products and processes
- Supports compliance and training efforts for GMD or suppliers related to the Quality Management System
- Drives continuous improvement activity and develops corrective actions that reduce waste and support key company objectives
- Participates in development and implementation of QSR training programs
- Performs other duties and special projects as required
Supervisory Responsibilites:
Provides strategic direction and oversight for quality processes, systems and controls
Travel Requirements:
Up to 35
Minimum Requirements And Qualifications:
The requirements listed below are representative of the knowledge, skill, and or ability required for this position.
- Bachelors degree in appropriate discipline or experience equivalency
- 5years experience in manufacturing or contract manufacturing quality control function
- Experience in a start-up or early stage medical device company
- Exposure to manufacturing process engineering, development and troubleshooting
- Must have working knowledge of statistical techniques and test and experimental design
- Demonstrates the ability to provide a logical, in-depth analysis of a problem or situation
- Excellent teamwork skills to support conflict resolution and create effective solutions to develop, maintain and comply with quality systems to support broad business need
- Must have relevant experience with medical devices, in an ISO 13485 / FDA QS environment
- Must have excellent written and oral communications skills
| Location: | 2201 34th Avenue NW Gig Harbor, WA 98335 United States |
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THIS JOB HAS EXPIRED
Generic Medical Devices
Investors: Kaiser Permanente Ventures, Latterell Venture Partners, The Grosvenor FundsAll Jobs: at Generic Medical Devices
| Web Site: | www.genericmedicaldevices.com |
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| Headquarters: | 2201 34th Avenue NW Gig Harbor, WA 98335 United States |
| Industry: | Medical Devices and Equipment |
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