Careers

Why join us?

Datum Dental is an innovative and vibrant company. We hire highly talented team players, who are passionate about science, technology, medicine and making a difference. The Company was founded in order to develop, manufacture and market a full line of dental biomaterial products for tissue and bone regeneration. Datum Dental’s headquarters include R&D, sales, marketing, QA/QC and manufacturing facilites.

Priority & Business Technologies Manager

In this role, you will join the Regenerative Platform, in a dynamic and exciting global medical device company, in a fast-paced growth environment.
Job description:
  • Implementation and assimilation of business processes in the Priority system
  • Writing Specification document.
  • Meet system user requirements, providing user support and training.
  • Performing acceptance tests for developments on the Priority system.
  • Support Module: finance, production, sales, procurement and more.
  • Support system user onboarding and offboarding processes.
  • Define and Adding Priority system reports.
Required skills:
  • Industrial and management/information systems engineer - an advantage
  • Experience in writing specification document, user requirements and defining processes.
  • Full knowledge and control of the Priority system and its main modules - at least 3 years of
Experience:
  • Familiarity with the processes of production, procurement, sales,
  • Understanding of business, logistical, and financial processes - an advantage
  • Excellent human relations - a must
  • English at a high level - mandatory
  • The position is intended for both women and men.

Quality Validation Engineer

Datum Dental is seeking to hire a full-time Quality Validation Engineer. In this position you, participates in the various Quality Engineering efforts, specifically related to the overall Quality Planning activities, which may include equipment validation, software validation.
Key Responsibilities:
  • Provides technical expertise in Quality Planning activities, which may include: Risk Assessment support (FMEA), specification development for Raw Materials/ Components, Intermediated, Bulk, Finished product.
  • Provides technical expertise in the introduction of new product through FMEA and process capability analyses as well as designing and implementing design verification/validation plan, protocols, and reports.
  • Guides and directs engineering in the development of robust and efficient process and design validations with core teams, as well as perform testing methods.
  • Expert in applied statistical methodologies (MSA, DOE, Sampling Plans, SPC, etc.) to support site/SBU validations and inspection requirements. Trains employees in the concepts of probability and statistics.
  • including such information as the number of units to be inspected/tested, the frequency to test, test methods and yield determination.
  • Leads process and product audits as well as internal Quality System audits.
  • Identifies areas for improvement and leads the effort for continuous process improvement.
  • Acts as liaison between departments and make independent decisions to ensure adherence to quality procedures.
  • Establishes, collects, and analyzes data for metrics reporting for results of activities to identify areas of potential improvement.
  • Executes verification and/or validation protocols for products and/or processes.
  • Prepares reports for management and senior management as required.
  • Works with all business units to improve material flow, ensure process quality, reduce work in process, and achieve required capacity/cycle time requirements to meet or exceed customer requirements.
  • Leads problem/root-cause investigations for acute defect problems
  • Other duties as assigned.
 Typical Background:
  • Bachelor’s Degree in Engineering or another related technical discipline OR Master’s Degree in related discipline
  • Certifications/Licensing: ASQ Certified Quality Engineer or Six Sigma Black Belt, required
  • 2-4 years related work experience
  • Prior experience in medical device industry preferred
  • 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, diagram, or schedule form.
  • Ability to define problems collects data, establish facts, and draw valid conclusions.
  • Able to formulate an approach and plan projects.
  • Ability to understand mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentage, ratios, metric measurement and proportions to practical situations.
  • Lead, manage, and implement initiatives to support the QA/RA Department goals and objectives.
  • Ability to Make recommendations based on review of numerical data, written reports and trends.
  • Strong problem solving skills; able to come up with alternative solutions for management consideration based on data analysis.

Process Development Engineer

Datum Dental is seeking to hire a full-time Process Development Engineer. In this position you The Senior Process Development Engineer will develop chemical processes for the manufacturing of a wide array of materials.  Participation in all aspects of process research, development, and design will be required: chemical and physical modeling; laboratory-scale experimentation; pilot-scale development; and plant implementation. The development team works with an extremely varied chemical portfolio including specialty organic chemicals; organic resins and adhesives; polymer materials; inorganic glasses, minerals, and composites; and pharmaceuticals. Production scale is small to moderate, allowing for rapid product introduction and frequent innovation.  Work will be performed within an FDA/ISO regulated facility requiring the development and execution of appropriate validation/qualification protocols. Individual technical contribution is at least 50% of this role; however, management of technical project teams will be a key part of the Chemist/Engineer’s success.  Mentoring of junior technical staff, coordination of research teams, and management of new chemical synthesis projects will be expected. The Process Engineering team is responsible for the introduction of all new chemical products to two manufacturing plants.  We also evaluate existing manufacturing operations; establish procedures to gain optimum utilization of equipment; review production requirements; and recommend process improvements.
Key Responsibilities:
  • Management of new-process and process-improvement projects through development, implementation and start up. Lead cross-functional teams to support resolution of product and/or process related issues or objectives.
  • Develop, Design, and Scale up new chemical processes from the lab to the manufacturing environment. Hands on participation in all aspects of new process development: laboratory-scale and pilot-scale simulation, process design, start up, and process monitoring.
  • Initiate, develop and execute validation/qualification protocols.
  • Evaluate production processes and provide recommendations for improvement for raw material/components/formulation designs to help ensure processes and products are capable and robust throughout the life of the product.
  • The safe operation of complex instrumentation to perform quantitative and qualitative chemical analyses. Must be proficient in the setup and use of laboratory equipment and assist in the preparation of process and mechanical drawings.
  • Establishing SOP’s and the training of manufacturing personnel during the initial start-up phases of new production processes and/or procedures.
  • Keeping up to date on chemical processes and products to provide technical support and direction to production personnel.
  • This position requires a high degree of technical skill level and chemical background
Typical Background:
  • Degree in Chemistry or Chemical Engineering
  • 5 years of experience in Chemical Process Development, scale up, and implementation is required
  • Experience in project and team leadership is required.
  • Strong chemistry background with a focus on scale-up, pilot-scale manufacturing and process development
  • Extensive chemical process laboratory experience
  • Strong varied knowledge of chemical processing
  • Demonstrated ability to lead teams and manage projects.
  • Ability to analyze data with various statistical programs and prepare reports.

Senior QA Director

In this role, you will join the Regenerative Platform, in a dynamic and exciting global medical device company, in a fast-paced growth environment.
Responsibilities:
  • To lead, coordinate and plan the work within the dedicated QA/QC Team.
  • Evaluate and improve QA processes.
  • To coach and lead the dedicated QA/QC Team in order to develop adequate competencies, efficient working methods, optimal use of resources and a stimulating working climate
  • To maintain and continuously improve procedures and instructions related to area of responsibility, compliant to FDA, MDD/MDR and all applicable regulatory and corporate requirements.
  • Secure CAPA Process are implemented and followed within the organization.
  • Foster a philosophy of continuous improvement in the organization, including Management of Nonconformities when needed.
  • Perform Quality Review of documents related to the QMS.
  • Actively take part in the Change Control Process as QA representative. Member of the PCO Board.
  • Actively take part in Design Transfer activities such as Purchase Approval and Production Start Process
 
Requirements:
  • Bachelor’s degree in sciences
  • Experience from working within QA/QC in a Medical Device Industry, preferable class III
  • Experience from acting as People Manager within QA/QC,
  • Experience from participate in External Audits for example Notified Body Audits
  • Knowledge within ISO 13485, FDA Quality System Regulation 21 CFR Part 820
  • Knowledge about EU MDR (Medical Device Regulation and EU MDD (Medical Device Directive)
  • Very good English – for writing professional documents.
  • Very good knowledge with Word/Excel/Power point

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