Fitchburg, MA 01420
- Adhere to all company policies and to act as a role model in the adherence to policies application/interpretation and customer expectations
- Assist in the quality system training for new employees. Also provide support to other departments for training on changes
- Develop and analyze production and statistical data to assure processes yield expected quality levels and to identify opportunities for improvements within the operation
- Develop and implement statistical sampling plans
- Develop qualification/validation plans and coordinate product/process validations
- Have a basic understanding of quality management systems related to ISO 9001/ISO 13485/ISO 14001/OSHAS 18001
- Monitor quality metrics and progress towards goals and objectives.
- Identify trends and opportunities for improvement
- Perform and document customer complaint investigations.
- Assist Quality Manager with findings to assure actions are effective
- Perform supplier audits as required to assure consistency of supplied products and work with suppliers to resolve quality issues
- Provide support to manufacturing, project and product development activities.
- Review results and provide recommendations for changes/improvement
- Provide training support in the areas of all ISO 9001 standards, Micron Quality System requirements, auditing, statistical process control
- Set up inspection/metrology equipment and Incoming Inspection processes.
- Verify the effectiveness of quality testing and inspection activities
- Support the corrective and preventive action process and assist Quality Manager is verification of effectiveness
- Bachelor of Science in Engineering or Science or a minimum of 10 years in a Quality Assurance position required.
- CQE (Certified Quality Engineer) a plus.Experience with SPC and MRP software a plus.
- Medical Device development and manufacturing experience.
- Must have experience in the areas of metrology, auditing and statistical analysis.
- ISO 9001 experience required; ISO 13485 very desirable.
- Must possess computer application skills primarily MS Office.
- Strong facilitation and communication (written and verbal) skills required.
- Validation experience preferred.
- Strong organizational skills needed.
- Ability to work independently and strong process control background.
Client Relationship Manager
John Sabbagh has over 10 years of recruiting experience. Starting his career as an Entry Level Recruiter at Panther, our candidates find him genuine and great resource to their career search!
Fun Fact: John is a sports fanatic, he plays in horseshoe and cornhole leagues and loves fantasy football.