The incumbent applies engineering and quality assurance principles and techniques to the product development lifecycle for disposable products. The position will also perform complaint investigations and testing for NxStage disposable medical devices and support of the Quality System.
NxStage is an Equal Opportunity Employer
The following represents some of the main responsibilities of the above position. This list is not in any order of importance and should not be considered an exhaustive list of possible duties of the position. NxSTAGE Medical, Inc. maintains the right to modify this list at any time.
- Conduct thorough product complaint investigations as assigned for device-related incidents to determine root cause and recommend appropriate corrective and preventive actions.
- Assist in developing and establishing quality systems programs and plans that ensure compliance with the Quality System Regulations.
- Develop and implement instructions/methods for inspecting, testing and evaluating product conformance to specification.
- Assist with and perform audits for evaluation of supplier compliance with the Quality System Regulations.
- Conduct internal audits for evaluation of compliance with the Quality System Regulations.
- Process non-conforming material reports including MRB dispositioning.
- Assist in supporting manufacturing in the investigation of manufacturing problems and product complaints to determine the root cause and recommend appropriate corrective and preventive action to prevent recurrence.
- Assist in maintaining quality system information databases as assigned. Evaluate quality data and prepare periodic reports to monitor trends.
- Complete activities associated with the formal release of product to finished goods.
- Support Engineering in the development, testing, verification, validation and commercialization of new products.
- Assist in Risk Analysis including, Fault Tree Analysis (FTA), Operator Misuse Analysis (OMA), and Failure Mode and Effects Analysis (FMEA) activities to ensure process shortcomings are identified and appropriately addressed.
Education & Qualification:
- 3+ years related quality assurance, quality engineering experience or an equivalent combination of experience and education. Medical device experience preferred.
- ASQ certification a plus.
- Understanding of statistics required – Cp, Cpk, AQL, etc.
- Intermediate knowledge of FDA Quality System Regulation 21 CFR Part 820.
- Good organizational, attention to detail and follow-through skills.
- Excellent verbal communication and customer interface skills.
- Ability to interface with multiple groups in the organization.
- Basic computer skills – word processing, spreadsheet, windows. MS Office preferred.
- Must be willing to travel, mainly to suppliers in the US and some international.
- Willingness to contribute to other departments as necessary.
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