Chelmsford, United States
11 months ago
Quality Assurance Engineer
The primary purpose of the position will be ensuring that complaints are properly investigated and documented as well as verifying that outgoing units comply with stated guidelines. In addition, the position supports the resolution of customer issues in order to determine the cause of the problem and to initiate the appropriate corrective action. In some cases, formal reports to customer will be required to explain the problem and what was done to correct it. Moreover, the Quality Assurance Engineer will be required to conduct analysis and trending of information and perform inspections on incoming finished goods.
- Ability to lead product quality investigations to a successful conclusion.
- Perform pre-release final inspection on medical devices, flagging and trending any non-compliances.
- Identify and help facilitate continuous improvement, corrective and preventive actions (CAPA).
- Interface with other departments as necessary to provide assistance in CAPA execution.
- Collect, analyze, trend and communicate quality data throughout the organization.
- Execute risk assessments, collect supporting information and provide recommendation to management.
- Ensure daily procedures and work instructions are in accordance with established internal procedures, ISO and Health Canada requirements.
- Contribute to the maintenance of the ISO 13485:2016 quality system manual.
- Plan and conduct internal process audits and facilitate ISO and Health Canada facility audits.
- Ensure SOPs are in line with Health Canada policies and guidelines.
- Provide support in product investigations.
- Practice dynamic communication within all facets of to ensure smooth workflow and timely completion of tasks.
- Ability to analyze and identify trends.
- Basic ISO 13485:2016 audit and procedure writing knowledge.
- Proficient with MS Office.
- Excellent communication skills.
- Ability to work independently.
- Minimum 1-3 years related experience in a regulated environment, preferably medical devices.
- Four year engineering degree required.
- Experience with statistical analysis.
- Experience maintaining a quality manual preferred.