Manage and enhance the Quality Management System (QMS) of Columbia Tech through Supplier Development initiatives and for implementing quality related-programs and projects. Lead Supplier Quality improvement efforts designed to ensure continuous quality improvement.
Duties and Responsibilities
- Ensuring that supplier quality requirements are effectively established and effectively maintained in accordance with all applicable standards and regulations.
- Partners with Supply Chain and Supply Chain Management to align on supplier quality management strategy.
- Report to the General Manager and the Management Team, a minimum of twice a year, on the performance of supplier quality and any need for improvement.
- Promote awareness of customer, statutory, and regulatory requirements throughout the organization.
- Continuously develop, implement and oversee supplier quality assurance and supplier regulatory compliance for the company.
- Support maintenance of ISO 9001 certification.
- Provide leadership and management for the Supplier Quality team for Columbia Tech.
- Lead the effective development, implementation and training of all Supplier Quality System procedures, work instructions, and forms to ensure compliance to ISO 9001.
- Establish and maintain employee training and development.
- Establish and maintain production monitoring systems for Suppliers and corporate auditing systems.
- Manage response to all Supplier Corrective Actions (SCARs).
- Analyze and report Supplier quality data for trends on a monthly basis.
- Establish meaningful Supplier Quality Report card
- Assist in interpretation & implementation of global standards requirements.
- Review technical publications, articles and abstracts to stay abreast of current regulations and trends, ensure appropriate actions are taken to incorporate necessary revision into workplace environment.
- Responsible for assuring adherence to various governmental policies, regulations, standards, procedures and guidelines under which the company must operate in regards to supplier quality and compliance. Specifically, this person may initiate action to prevent non-compliance; identify and document quality problems and subsequently initiating, recommending, providing and verifying solutions to product problems.
- Actively leads and participates with the Senior Vice President, Quality & Compliance in Company, and other regulatory inspections, including responding to observations, securing agreement of corrective actions, and overseeing the implementation of corrective actions.
- Partner with Quality Control to help maximize efficiency and effectiveness of incoming inspection process.
- Provide support to the company during internal & external audits.
- Identify, report, and recommend solutions to general compliance issues that may arise through the work process.
- Support and lead continuous improvement activities.
- Other duties as assigned.
- B.S. degree in Mechanical or Manufacturing Engineering desired.
- Positive attitude, self-motivated, tenacious follow up, and superior organization skills.
- Superior customer service attitude.
- Bachelor’s degree – Significant professional experience may be considered in lieu of certain educational requirements.
- 10+ years of experience and knowledge with implementation and maintenance of an ISO 9001
- Knowledge of ISO 13485 Quality System a plus.
- Experience with managing quality groups.
- Strong interpersonal skills; must be capable of effectively establishing professional rapport with internal personnel, various levels of management, and external partners.
- Effective organizational, communication, presentation, and writing skills.
- Thorough understanding of manufacturing quality process controls and statistical methods.
- Experience with FDA and Notified Bodies a plus.
- Generally works in an office environment, but may occasionally be required to perform job duties outside of the typical office setting.
- Must have a reliable form of transportation and ability to travel to other company locations.
- Flexibility to work extended hours when needed.
Note: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and/or skills required of all personnel so classified.