QA Engineer - Validation
Location: Somerset, New Jersey
To support the Quality Assurance group in review and approvals of Qualification and Validation documents. Continual improvement of the Qualification and Validation processes including Calibration/Maintenance, change management, computerized systems and software validation and other associated Quality Assurance areas. Works with other departments to resolve quality problems, and to initiate and facilitate activities that maintain and ensure the continued effectiveness of the Quality Management System.
- Work with the Manager of Quality Systems in maintaining Quality Systems policies and procedures to ensure regulatory compliance by following FDA QSR, MDD, MDSAP, ISO and any other regulatory requirements as assigned.
- Responsible for review and approval of documents and improvement of processes for:
- Qualification/Validation of new equipment and processes.
- Validation of computerized systems and software.
- Test equipment calibration/maintenance.
- Change management.
- Create or update QS procedures. Maintain procedures in the QA area.
- Monitoring and statistical analysis of quality and process data to identify areas of concern and unusual trends.
- Perform monthly Quality System checks and provide reports for quality meetings. Provide product data charts and analysis as requested for various review meetings.
- Identify, prioritize and drive continuous improvement opportunities for QA systems.
- 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, engineering or related field.
- Minimum 1 to 2 years 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 attention to detail, cross-checking, and verifying correctness of data.
- Exceptional organizational skills and ability to plan and implement resolutions to problems.
- Ability to communicate effectively with all levels in the company.
- Ability to facilitate programs and drive improvements within a competitive manufacturing environment where change plays a major role.
- 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.
- Computer literate in Microsoft Word, Excel, Access, and working knowledge of Windows.
- Knowledge of business management systems such as SAP, LABSQ and QUMAS preferred.
Ability to sit or stand for up to 8 hours per day, view computer monitor and move about effectively to fulfill the essential functions of the job.
Join us on our journey to shape the future of dentistry
Ivoclar Vivadent is one of the world’s leading dental companies with 3600 employees. We love innovation and we thrive on it. We are known for our long-standing experience and high quality. We are guided by our strong values and the company culture of a sustainably operated family-owned business with a long-term vision.
Our mission is making people smile
In order to achieve this goal we are looking for people with good ideas, courage and exceptional drive: focused minds who share our passion. We offer a multifaceted work environment, which is characterized by mutual respect and close collaboration. We translate words into action and continue to evolve. Become part of our team today.
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.