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Straumann Group: Senior Manager, Quality Management & Compliance

Straumann Group

This is a Full-time position in Laval, QC posted July 23, 2021.

About Dental Wings Company DescriptionFounded in 2007, Dental Wings is headquartered in Montreal (CA), with additional offices in Berlin, Chemnitz (D) and Lyon (F).

A fully-owned company of the Straumann Group since August 2017, Dental Wings products are distributed by leading dental companies in over 70 countries around the world.Our products cover the full digital workflow from treatment-planning to final restoration including intraoral scanning, implant planning, prosthesis design, manufacturing, and communication among dental professionals.#WeChangeDentistry every day.

Be part of it.

Job Description The Manager, Quality Management & Compliance:Accountable for compliance of quality management system to ISO 13485: 2016, MDSAP countries requirements, as well as integration of all applicable global regulatory requirements.Ensures that quality management system requirements are effectively established and maintained, with a risk-based proactive and preventive approach, and report on performance.Accountable for Design & Development quality oversight, including design changes, risk management, labeling management, and maintenance of design history file (DHF).Provides leadership and skills to develop a strong quality collaboration with business process owners and across the organization.Assures suitability, adequacy and effectiveness of the quality management system and assess opportunities for improvement and the need for changes.Accountable for the control of documents and records, and for the management of related changes.Ensures the identification of training needs and the administration of training deployment related to quality management system.Accountable for the development and execution of the annual internal audit program.Ensures readiness and preparedness to Internal, 3rd party, or external certification audits.Accountable for the management of reported nonconformities or potential nonconformities, and of the corrective and preventive action (CAPA) process.Accountable for quality process measurement and monitoring, and for the establishment and maintenance of key process indicators, quality metrics and trending.Ensures the Management Review is performed at planned intervals.Promotes a quality culture and compliance mindset though training, mentoring, and visual management practices.Other related tasks.

Qualifications University degree in Engineering (electronic, electro-mechanical, mechanical, or biomedical).7 years of experience in quality/compliance role within a regulated industry (preferably in medical device).3 to 5 years of experience in a supervisory/leadership role.Knowledge in product development and lifecycle management.Experience in Quality Improvement techniques and methods.Excellent communication skills.

Bilingual (English and French).ASQ Quality Management or Quality Engineer certification (asset).Knowledge of ISO 13485 and/or ISO 9001 Quality Management System standards (strong asset).

Additional Information What can you expect from us?An agile and ambitious environment: We are #ChangeMakers.Open, friendly colleagues who #collaborate and #support each other:We are #Players+Learners.The #freedom to #create and #engage: You can leave your #FootprintInDentistry.An employer who invests in our #inspiring corporate #culture.The #opportunity to develop yourself as a person and in your #career.

We #grow.#Attractive workplaces at great locations We are a #GlobalPlayer.To work for the No.

1 in #Dentistry and one of the leading #MedTech companies.and many things more!