The Quality Manager will be responsible for the implementation, maintenance of and improvement to the quality system program. The Quality Manager will be responsible for appropriately defining and implementing the quality system program to ensure compliance to product quality, customer expectations and regulatory requirements.
- Manage the quality department consisting of quality engineering, document control, metrology and inspection in accordance with the organization’s policies and applicable laws, including but not limited to training, planning, assigning and directing work.
- Responsible for compliance to 21 CFR 820, ISO 13485, Quality Manual and companywide policies including Management Review.
- Ensure a high level of internal and external customer service. Investigate and correct customer/company issues and complaints relating to quality
- Support implementation and continuous improvement of quality system processes
- Investigate and analyze customer/vendor/company concerns leading the NC/CAR review process, determining containment, disposition, root cause, corrective action and implementation of preventive actions.
- Maintain corrective action system and review effectiveness and implementation of corrective actions
- Leads the team engaged in inspection and testing activities to ensure high technical integrity.
- Formulate, document, and maintain quality control standards and on-going quality objectives.
- Integrates proactive quality measures in the production process to improve overall processes.
- Establish and implement quality procedures and specifications, testing procedures, and standards for raw materials and for in process and finished products.
- Management of Document Control to maintain Quality System Documentation, Device Master Record, Document Control, Request for Change, and External Standards
- Manage the internal audits of the Quality System
- Responsible for creating and delegating new employee training compliant with the site quality system as well as ongoing training for all existing employees
- Review operation processes and verify that proper gaging methods and proper frequencies are being used
- Implementing and monitoring most recent technologies in gaging to reduce variation in gaging processes
- Final authority to reject or accept product
- Bachelor’s Degree in field relating to engineering, manufacturing, or quality
- Minimum of 8 years’ experience in a manufacturing environment, preferably related to the medical device field. Injection molding experience preferred.
- Previous experience managing a quality team
- Able to manage multiple priorities with many time constraints
- Knowledge of ISO-13485 and FDA Regulations
- Skilled in the use of statistics and root cause analysis as they relate to production
- Excellent communications and organizational skills
- Excellent computer skills, utilizing word processing, spreadsheets, project software and statistical software as well as job control software.