Summary of Position with General Responsibilities:
This position is responsible for assisting the Quality Systems Manager in implementation and maintenance of the quality system and automated documentation system at Bard Medical Division. This position also is responsible for assisting with the daily functions associated with the Document Control Department which includes training coordination and management for BMD. This position works with assigned project teams to implement requirements of design control, change control and the quality management system. Activities shall be consistent with Bard, FDA, ISO and other applicable requirements. Scope includes all activities within the scope of the Quality Management System. Activities support regulatory compliance and risk management consistent with marketed product requirements for globally distributed medical devices.
Essential Job Functions:
- Assists the Quality Systems Manager to maintain the integrity of the documentation system and associated documentation.
- Serves as the liaison between the division documentation/change control system and the documentation/change control systems located within the manufacturing facilities.
- Provides training on the documentation/change control system and associated policies and procedures as well as other elements of the quality system.
- Assists with management of training activities and provides formal training and follow up reinforcement as needed to assure deployment of the quality system procedures
- Manages the Document Control and support staff to ensure proper implementation of their duties and responsibilities.
- May serve as a QA representative in developing and maintaining Division policies and procedures.
- Ensures the selection, orientation, development, and retention of a sufficient number of qualified staff to carry out the responsibilities of the department.
- Demonstrated management skills.
- Proficient in the use of a personal computer with intermediate level of keyboarding skills and advanced level of Excel and PowerPoint capability
- Strong interpersonal skills required in the areas of verbal and written communications, customer focus, service to internal customers, professionalism, coaching, influencing, and team building.
- Detail oriented, committed to accuracy, efficiency, and consistency.
- Working knowledge of medical device manufacturing system requirements- 21 CFR 820, EU Medical Device Directive required. Familiarity with Canadian CMDCAS system, Australian TGA, Japan PMDA, and the relevant elements of quality management requirements preferred.
- Experience in applying quality auditing, quality engineering and failure investigation principles or equivalent preferred.
- Ability to assimilate and apply new technologies and innovations to current needs.
- Ability to travel – 10-20% as determined by business requirements with potential extended assignments at other facilities to resolve problems.
- Ability to develop concepts and present them in a large group setting.
- Ability to work with and motivate personnel in other departments.
- Effective problem solving techniques and leadership.
- Knowledge and understanding of document control/change control practices, FDA Regulations and ISO Standards, Design Control System, and automated document control/change control systems.
- Ability to collect and analyze quality data and provide technical support (including statistical analysis) to the Quality System Manager and other team efforts.
Additional Desirable Qualifications Skills and Knowledge:
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Ability to collect and analyze quality data and provide technical support (including statistical analysis) to the Quality System Manager and other team efforts.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Education and/or Experience:
- Four-year Science, Engineering, Technology, or Business Degree; higher education a plus
- Seven (7) or more years of equivalent quality system or quality engineering related experience
- ASQ, CQE, CQA, certification preferred.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to use hands to finger, handle or feel. The employee is occasionally required to stand and reach with hands and arms and lifts and/or moves up to ten pounds. Employee is required to meet with other personnel in other areas of building. Specific vision abilities required by this job include close vision.
This position works in a normal office environment. The noise level in the work environment is quiet to moderate. This position also has exposure to laboratory environment and manufacturing environments with associated conditions.
Job ID 2016-9610