Making people smile is what we aspire to at Ivoclar Vivadent each day, with our innovative products and our employee oriented culture. Working at Ivoclar Vivadent, we share our strong values that promote a culture of mutual respect that you will discover at all our locations around the world. We have a passion to be successful and to create and innovate for our future in order to continue as a global leading company in the dental industry. Our ongoing employee development, education and training is one of the cornerstones that underlines the long-term and people focused orientation as a family owned company.
We offer an excellent opportunity for an experienced Manager, Quality Systems to Organize, plan, coordinate and execute various processes of the Quality Management System to ensure quality production of products consistent with established standards, and to drive continual improvement.
Assist the Director of QA/RA in maintaining Quality Systems policies and procedures to ensure regulatory compliance by following FDA QSR, MDD, and ISO requirements. Identify, prioritize and drive continuous improvement opportunities for QA systems.
Manage the facility validation quality review process. Support the validation team in evaluating and approving plans, reports and data generated to qualify processes, equipment and computer systems. Provide quality and regulatory oversight and review during the qualification/validation planning process. Perform compliance reviews of validation protocols and final reports in support of validation effort. Plan, generate and execute validation of quality management system improvement processes.
Facilitate and manage various aspects of change control process including the design transfer process. Review and approve future processes for change control by evaluating effects of change and ensuring internal processes are considered.
Manage the non-conformity, CAPA and supplier management programs.
Manage quality systems document handling and maintenance activities, including electronic data management, QUMAS system and the specification management process. Coordinate LMS activities as they pertain to regulatory training defined in the QUMAS system
Participates effectively in a leadership or membership role for joint local and corporate cross-functional teams as a representative of Quality Assurance. Ensures optimum team dynamics and results
Develop quality metrics, perform monthly Quality System Checks and organize periodic Quality Meetings. Champion changes in quality metrics, help introduce future metrics and trend reports, improve ease of reporting and ensure accurate and consistent metrics.
Develop, maintain and train on statistical methodology for decision-making and continuous improvement.
Authors and/or updates QS procedures. Maintains procedures relevant to scope of job description. Reviews and approves facility wide documents to ensure compliance with regulatory objectives and change guidelines.
Actively participate in third party audits. Function as primary contact for areas of responsibility.
Develop Quality Management staff so that personal growth and company objectives are met. Train, instruct, and orientate employees to company and departmental procedures. Identify training needs, ensuring they are delivered to appropriate staff on a continuous basis as required. Cross train employees to provide necessary coverage to meet business priorities. Support hiring and training directives through employee counsel and review of specifications.
Balance a multiplicity of demands in a responsive, professional manner to assure the quality assurance systems organization provides appropriate and timely support to meet business objectives.
Perform other related duties and assignments as required.
Minimum Bachelor's degree in the sciences or engineering. Master's degree preferred.
At least six years of relevant work experience in ISO13485 or ISO9001 regulated establishment.
Familiarity with interpreting regulations as they relate to quality systems. Working knowledge of FDA QSR, ISO13485 or ISO9001 standards preferred.
Exceptional organizational skills and ability to plan and implement resolutions to problems. Proven project management
Ability to communicate effectively with all levels in the company.
Ability to demonstrate achievements within a competitive manufacturing environment where change plays a major role. Proven track record of results and achievements.
Good interpersonal skills with the ability to interact and influence others to complete mutually agreed tasks per schedule.
Ability to effectively manage time to meet assigned deadlines and prioritize multiple work assignments. Ability to work independently with minimal supervision.
Excellent writing skills.
Previous audit experience, RAC or CQE certification.
Computer literate in Microsoft Word, Excel, Access, and working knowledge of Windows.
Knowledge of business management systems such as SAP, LABSQ and QUMAS.
Ivoclar Vivadent Manufacturing, Inc. offers competitive compensation, opportunity for training and advancement, medical and dental benefits, other voluntary benefit options, life and disability insurance, competitive time off program, 401(k) and pension plan, flexible spending accounts, corporate wellness programs, on-site fitness room, and a positive, up-beat work environment!
Ivoclar Vivadent Manufacturing, Inc. is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. EOE/AA. Minority/Female/Sexual Orientation/Gender Identity/Disability/Vet.