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Straumann Group: Head Of Quality, Regulatory And Customer Technical Support

Straumann Group

This is a Full-time position in Montreal, QC posted July 10, 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 Head of Quality, Regulatory and Customer Technical Support is a key leadership position supporting and driving growth through innovation, while developing a strong Quality culture and customer-centric mindset across the organization.

The main areas of responsibility include: Quality System, Regulatory Compliance, Quality Verification and Validation engineering, Quality Assurance in Operations, and Post-Market Quality.

This role will provide quality support and solution-based decision making to enable delivery of the product roadmap, while maintaining product quality and quality system compliance, with prevention of quality issues and driving continuous improvement.

The Head of Quality, Regulatory and Customer Technical Support will provide strategic leadership and have the technical and tactical skills to develop a strong global Quality Function in collaboration with the rest of the organization.Responsibilities may include the following and other duties may be assigned:Through strategic and proactive leadership, develop and implement the Dental Wings business and product Quality strategy that drives significant improvements, is aligned with the Digital Business Unit and Straumann strategic priorities, and fosters a strong Quality & Compliance culture.Responsible for ensuring that quality and reliability goals are set early in the design process and development practices and incorporate current and appropriate worldwide regulatory compliance expectations (including MDSAP, FDA QSR, ISO 13485, and European Medical Device Regulations) for design controls and risk management.Ensure the implementation of processes to enable the highest reliability in new product introduction programs according to DFSS principles and with rigorous design transfer into production, all in collaboration with cross-functional partners.The position leads a global Quality team dedicated to driving significant improvements in our products and processes, with a predictive and proactive mindset of quality throughout the product lifecycle.

Drive improvements in product quality and quality system compliance through manufacturing quality, supplier quality, post-market quality performance, quality system and internal audit.Develop and deploy strategies that harness standard work, drive best practices, and continuous improvement to provide a compliant, effective, and efficient level 2 technical support process that improves performance to customer expectations and in alignment with overall quality objectives.Advise senior management on developments in regulations and standards that may impact company strategies and programs.

Direct development and presentation of periodic reports describing compliance trends and identifying areas of potential risk to senior management.Act as management representative to ensure that quality management system requirements are effectively established and maintained, reporting to top management on the performance of the quality management system, and ensuring the promotion of awareness of regulatory requirements throughout the organization.As a management representative, your authority includes: sign-off authority for changes to procedures, processes, designs etc; act on behalf of top management during audits; place products or processes on hold; manage quality audit functions; contribute to corrective and preventive action activities, complaint handling and the handling of nonconforming product.Design organization structure, and develop organization, aligned with required capabilities to deliver quality to our customers.Ensure quality systems policies and procedures meet applicable standards and specifications and align to Straumann quality standards.Implement processes and policies in compliance with DBU and Straumann quality strategies to ensure financial and strategic goals are attained.Lead all the global regulatory activities by providing strategic organizational direction to ensure that responses to quality-related regulatory queries are timely and complete Qualifications Bachelor’s degree15 years of relevant experience with 10+ years of managerial experienceTechnical Knowledge and design experience.

In depth practical knowledge of software quality engineering, reliability engineering, risk management, MDSAP/FDA and global regulationsAbility to develop, socialize and execute strategies to drive business & customer valueAbility to identify, develop and establish effective business processes compliant with regulatory and industry standardsAbility to directly and indirectly manage teams and individuals to achieve high levels of performanceAbility to communicate effectively in multi-discipline environment, and across functions, cultures and levels of organizationSix Sigma or Lean Certification(s) or continues improvement skillsExperience with start-ups and / or fast paced product commercialization growth 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!