Quality Assurance Engineer II job in Acton, MA
Vacancy has expired
Acton, MA CorTech LLC
| Job Ref: | 349001 |
| Employer: |
CorTech LLC |
| Job Type: | Contract |
| Salary and Benefits: | 54.29/Per Hour |
| Remote: | No |
Location |
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| City: | Acton, MA |
| Post Code: | 01720 |
| Map: |
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Description |
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JobsRUs.com. is seeking to hire a Quality Assurance Engineer II for our client in Acton, MA! Benefits Available! Weekly Pay! $54.29/Hour Shift: 1st Description ESSENTIAL FUNCTIONS Complaint Investigations (Time Spent: 45%): Review individual complaints and associated service data to determine risk level and complete investigation into the ?as ?determined? problem code and cause codes for each complaint. Analyze data from various quality inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determining trends and systemic issues. Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions. Conduct corrective and preventive actions in manufacturing using formal problem-solving tools and documentation. Support CAPA and maintenance activities for existing product lines. Recommend and/or support projects for improvements to the quality system as approved by management. Nonconforming Material Review Board (Time Spent: 45%): Support material review board Develop dispositions for nonconforming material using engineering / risk-based rationale. Coordinate the quarantine of nonconforming material. Communicate with suppliers about material that does not meet specification. Other (Time Spent: 10%) Provide quality support to various improvement projects Perform quality duties as assigned by Quality Manager QUALIFICATIONS, KNOWLEDGE, AND SKILLS REQUIRED To perform this job successfully, and individual must be able to perform each essential duty satisfactorily. Required: Knowledge and working application of reading and understanding blueprints and technical drawings. Demonstrated strong analytical problem solving (Root Cause Investigations). Computer competency in Word, Excel, Power Point Ability to multi-task and methodically manage projects. Critical thinking Attention to detail Collaboration & Teamwork Dealing with Ambiguity Strong ability to balance multiple priorities Preferred: Medical Device Experience with knowledge of 21CFR820 preferred / ISO 13485 / FDA cGMP Competency in SAP Desired experience in the medical device industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods. EDUCATION/EXPERIENCE REQUIRED A Bachelor of Science degree in Engineering 0-3 years of Medical Device experience PHYSICAL DEMANDS Able to exert up to 10 pounds of force occasionally. Able to sit, stand, walk throughout the workday. | |
ref: (349001)
936 days ago
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