The Quality Engineer is responsible for the safe and effective operations of the site quality control functions. The Quality Engineer is responsible for overseeing all aspects of quality compliance, implementation & development of quality systems and ensuring efficient and effective quality assurance for all products.
This role will interface cross functionally to ensure compliance with ISO9001 and other relevant standards, as well as global QMS requirements.
- Responsible for supervising maintenance, calibration, and analysis for laboratory instruments.
- Align and participate in and support all aspects of the sites Continuous Improvement programs.
- Responsible for supervising in-process and final testing for raw materials, intermediate materials and final products.
- Responsible for ensuring Quality ERP Master data is entered properly.
- Comply with global, and site QMS processes and procedures.
- Drive reduction of COPQ, customer complaints, and first pass reject rates.
- Support Customer Complaint, Product failure, and audit root cause investigations and corrective/preventive action implementations.
- Support Supplier and external Quality activities including supplier corrective action requests, audits, and evaluations.
- Ability to lead Quality activities in supporting Engineering tests and Validation plans.
- Drive effective RCCA process for the sites.
- Identify and lead process improvement projects including facilitating of process improvement events that improve product quality and/or reduce process variation.
- Responsible for customer specification reviews and ensuring the site meets the agreed to customer specifications.
- Create and/or Support Internal Audit plan and perform Internal Audits.
- Implement and maintain site QMS in accordance with the ISO9001 or other relevant standards and global QMS requirements.
- Create work instructions & procedures and provide training on relevant processes.
- 4 year undergraduate degree in science, engineering or similar field of study, technical major preferred.
- 5+ years’ experience in quality, process engineering, or related role.
- Continuous Improvement.
- Knowledgeable of Quality Standards, including ISO, IATF, FDA.