Quality Assurance Manager

Ivoclar Vivadent Somerset , NJ 08873

Posted 2 months ago


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.

See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Technical Program Manager


Posted 3 days ago

VIEW JOBS 11/16/2018 12:00:00 AM 2019-02-14T00:00 Conduent is the world's largest provider ofdiversified business process services with leading capabilities in transaction processing, automation,analytics and constituent experience. We work with both government andcommercial customers in assisting them to deliver quality services to thepeople they serve. We manage interactions with patients and the insured for a significant portionof the U.S. healthcare industry. We are the customer interface for largesegments of the technology industry and the operational and processing partnerof choice for public transportation systems around the world. Whether it's digital payments, claims processing, benefit administration,automated tolling, customer care or distributed learning - Conduent manages andmodernizes these interactions to create value for both our clients and theirconstituents. Learn more at www.conduent.com. Job Overview We are looking fora Senior Technical Program Manager who will bepart of Conduent Technology Services organization and will lead ourprogram management efforts within each of the businesses under CTS. Theideal candidate will be an outstanding manager who can leverage theirthought leadership and project management competency to help lead and managethe portfolio. The successful candidate must have exceptional problem solvingskills, strong business judgment, and demonstrated experience managingcross-functional teams. This role requires excellent technical acumen andinternal/external client facing tact! This role will beresponsible for the following responsibilities: Responsibilities: * Drive Conduent's technology platforms, solutions and execution. * Organizing programs and activities in alignment with organization mission and goals. * Develop new programs to support the strategic direction of the organization. * Create and managing long-term goals. * Developing a budget and operating plan for the program. * Developing an evaluation method to assess program strengths and identify areas for improvement. * Ensuring goals are met in areas including customer satisfaction, safety, quality and team member performance. * Producting accurate and timely reporting of program status throughout its life cycle. * Work closely with various Conduent business groups and clients to understand the problems, improve collaboration and seek opportunities to drive technology platforms and solutions in relevant areas of business * Establishes and assures adherence to budget, schedules, work plans, and performance requirements. * Regularly interacts with senior management or executive levels both within Conduent as well as on client side. Support includes project and operations planning, control,reporting, risk management, personnel management, and implementation support.Key skill sets include: Requirements: * The ideal candidate will at least have a Bachelor's degree in a technical field (e.g. Computer Science, Engineering). Masters degree is highly desired. * Minimum 10 years of industry experience in product development from market strategy through ideation, prototyping to product launch including at least of 6 years of technology management experience. * The ability to lead software-centric projects leveraging SharePoint, MS Project, O365, and other Microsoft technologies for a varied user base. * Deep knowledge and experience with distributed systems design and development. * Understanding industry trends and future state technologies and their applicability to different areas of business * Proven track record of strong verbal/written communication & system solutioning skills, including an ability to effectively communicate with both business and technical teams across the world * Affinity for science and the scientific discovery process * Good technical comprehension and excellent communication skills. Experience communicating with highly technical requirements, and translating highly technical topics to business teams. * Experience with design thinking, innovation lifecycle of software development (prototyping, ethnography, fail early etc.). * Experience coordinating activities across multiple infrastructure, data, security, and policy support organizations and stakeholders while managing distributed team resources * Exceptional written and verbal communication skills, familiarity/experience with leading Agile Scrum and Waterfall projects, and a demonstrated team player style/approach. Project manager must understand implementations and protections of PII, code modernization and transformation, and developing and executing "as-is" architectures into "to-be" architectures. Minimum eight years Project Management experience. * Agile Scrum support may include organizing and facilitating scrum meetings; developing and managing project plans, roadmaps and backlogs; communication, escalation, and monitoring; and product owner & stakeholder coordination; and reporting velocity, status, etc. according to defined reporting parameters. * The selected candidate may be required to provide support outside of normal business hours (nights, weekends, early mornings, etc.) to support technical deployments requiring support during non-standard hours. These hours will be addressed as needed on a case-by-case basis. * Experience, desire and comfort to build and work with teams located across many locations. Additional Requirements * Experience with other tools such as SalesForce, AINS eCASE,Cerenade, and proprietary CBP/WCR/BEMSD applications is desired but notrequired. * Ability to quickly learn new technology domains and interact in arich way with the research and engineering communities in addition to lines ofbusiness. * Strong oral communication skills including ability to makepresentations and prospect with clients * Strong analytical skills, computer skills and excellentorganizational skills * Ability to work independently as well as on a team with limitedsupervision * Excellent collaboration and negotiation skills * Ability to travel (25%) may be required * Proven program management skill set * Results driven with a positive attitude Conduent is an Equal Opportunity Employer and considers applicants for allpositions without regard to race, color, creed, religion, ancestry, nationalorigin, age, gender identity, gender expression, sex/gender, marital status,sexual orientation, physical or mental disability, medical condition, use of aguide dog or service animal, military/veteran status, citizenship status, basisof genetic information, or any other group protected by law. People withdisabilities who need a reasonable accommodation to apply for or compete foremployment with Conduent may request such accommodation(s) by clicking on thefollowing link, completing the accommodation request form, and submitting therequest by using the "Submit" button at the bottom of the form. Forthose using Google Chrome or Mozilla Firefox please download the formfirst: click here to access or download the form. '1865789 Conduent Somerset NJ

Quality Assurance Manager

Ivoclar Vivadent