5 Jobs in Westborough, MA
Katalyst Healthcares & Life Sciences is Hiring a Manufacturing Quality Engineer Near Westborough, MA
- Responsible for ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
- Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools.
- Provides development and implementation support for process verification and validation plans, equipment qualification documents and Validation Plans (Product or Process specific plans).
- Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops, and implements effective and compliant solutions for product or process corrections, action plans, and for corrective and preventive actions (CAPA Program).
- Utilizes risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Failure Mode Analysis, etc.
- Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process.
- Bachelor's degree
- 5 years Quality Assurance/Quality Engineering experience in the medical device or pharmaceutical industry.
- Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
- Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies.
- Demonstrated experience using word processing, spreadsheet, and presentation software.
- Demonstrated understanding of continuous quality / process improvement tools.
Job Summary
Contractor
$102k-125k (estimate)
05/30/2024
06/24/2024
katalysthls.com
South Plainfield, NJ
<25
Related Companies
The job skills required for Manufacturing Quality Engineer include Analysis, ISO, Process Improvement, Product Development, Quality Assurance, Presentation, etc. Having related job skills and expertise will give you an advantage when applying to be a Manufacturing Quality Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Manufacturing Quality Engineer. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Manufacturing Quality Engineer positions, which can be used as a reference in future career path planning. As a Manufacturing Quality Engineer, it can be promoted into senior positions as an Industrial Engineer IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Manufacturing Quality Engineer. You can explore the career advancement for a Manufacturing Quality Engineer below and select your interested title to get hiring information.
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