Do you want to join a team environment where you get to use your technical abilities to produce high quality dental equipment?

DentalEZ is a growing manufacturer of dental equipment who is hiring in Lancaster, PA! We are looking for outgoing and motivated individuals to join our team!

What's in it for you?

-Competitive Wages

-Work/Life Balance

-Full benefit package including 11 paid holidays, 15 days of paid time off, a company 401(k) match, and insurance

-Clean, safe, and climate controlled work environment

-Stable work in an essential business

-Small interpersonal culture

-Great benefits, including medical, dental, and vision insurance

SUMMARY DESCRIPTION AND SKILLS:

The Quality and Regulatory Affairs Manager is responsible for the maintenance of the Quality System compliant to the ISO 13485 standard for Class I and all Devices and FDA medical device requirements including internal audits and training activities. This position is also responsible for keeping abreast of any regulatory requirements or changes applicable to the product in worldwide target markets.

Essential Duties and Responsibilities

• Subject matter expert in Quality and Regulatory compliance, contributing to attaining and maintaining the required registrations/certifications to sell product globally.
• Manages and oversees the Quality Management System; ensure best and most current practices are leveraged company wide.
• Collaborates internally and externally to determine customer requirements and ensure they are met.
• Partners with critical suppliers to maintain the highest rate of supplier performance and compliance.
• Establishment and use of metrics to monitor the suitability and effectiveness of the QMS.
• Develops,maintains and followsISOproceduresand GMPrequirementspertaining to medical devices.
• Responsible for managing the RMA, QC Inspection, document control personnel & processes, Acceptance Activities, Calibration Process, Quality Management System (QMS) Training Process, Material Review Board, and Quality Engineering activities.
• Advisespersonnel and projectteams on quality system and regulatoryrequirements, coordinatesand presentsregulatoryinformation, and negotiates with and influencesmanagement and colleagues to ensurerequirementsare met.
• Ensures that company and quality system are compliant with all federal, state, local and company specific regulations as they apply to medical devices or a medical device facility; responsible for ensuring that internal and external audits are performed per current regulatory guidelines/procedures.
• Coordinate with externalconsulting resources as needed.
• ManagetheInternalAudit, CAPAprogram and Supplier CAPA program.
• Work with processowners of CAPAsand internalauditfindings and ensureappropriate corrective actions plans are implementedand verifiedfor effectiveness.
• Provide oversight to the on-going maintenance of the Quality System procedures; ensure that changes to the procedures are consistent with the intended structure of the Quality System.
• Familiarity with and implements Six Sigma, lean manufacturing, ISO 9001, and similar principles or standards.
• Assesses project risks and adjusts as necessary to ensure proper regulatory compliance.
• Develops and implements regulatory strategies regarding the preparation of new products.
• Oversees audits, inspections, and product recalls. Serves as the primary point of contact for technical product development teams.

Education and/or Experience:

• Minimum of a 4 year degreefrom an accredited university.
• ASQ CQA and/or CQE certified.
• Strongknowledge of ISO/FDAregulations and procedures for medical devices.
• Familiar with the FDA510(k)submission process,ISO13485standard and CEmarking activities.
• Familiar withFDAEstablishmentRegistration,FDADeviceListings,FDACertificatestoForeign Government.
• Experience as a cross-functionalprojectmanager(i.e. can effectivelywork with legal,marketing,sales,engineering, IT, support,andoperationsgroups).
• Familiar withtechnical details of medicaldevicesconcepts, practices, and procedures.
• Abilitytoread,analyze,and interpretstandards and regulations.
• Abilityto managecritical projectstodeadlines as part of an interdisciplinary team.
• Strong interpersonal, oral and written communicationskills with theability to effectivelycommunicate with all levels of the organization,customers and suppliers.
• Presentation skills,technicalwriting and editing skills.
• Strong attention todetail and excellentorganizationalskills.
• Proficiency in using a personal computer, including Windows-based applications.

We are an Equal Opportunity Employer, including disability and veteran status.

If you are interested in applying for employment with DentalEZ and need assistance or an accommodation to use our website, please contact us by email or phone.

Email:

Support@applicantpro.com

Phone: 888-633-9269