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Quality System Manager - Remote

Company

Dentsply Sirona
Address , , De
Employment type
Salary
Expires 2023-07-16
Posted at 11 months ago
Job Description
Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona’s products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona’s global headquarters is located in Charlotte, North Carolina. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY.
Bringing out the best in people

As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we’re looking for the best to join us.

Working at Dentsply Sirona you are able to:

Develop faster - with our commitment to the best professional development.

Perform better - as part of a high-performance, empowering culture.

Shape an industry - with a market leader that continues to drive innovation.

Make a difference -by helping improve oral health worldwide.


Key Responsibilities:

Supplier Management
  • Define & implement quality supplier control guidelines and procedures aligned to ensure that supplier (for raw materials, components and finished goods) and sub-contractors comply with product specifications.
  • Responsible for managing the supplier development and approval and maintaining the assessment system.
  • Initiates meetings with vendors, manufacturing, R&D and other areas to discuss and resolve quality issues
  • Accountable for establishment, review and implementation of supplier quality agreements
  • SCARs management including establishment, communication and follow-up
  • Overall management of the supplier audit program
  • Propose and implement continuous improvement for supplier management process.
  • Monitors and reports supplier related metrics to ensure compliance with performance criteria and pursues corrective action to address non-conformances.
  • Coordinates with sites to ensure that Supplier Audits and performed on-time and efficiently.
  • Maintaining global approved supplier list.
  • Working with manufacturing site Supplier teams, implement and maintain Supplier Management from a quality perspective, including:
    • Assures all vendors are appropriately evaluated and approved to consistently meet product requirements
    • Maintaining global approved supplier list.
    • Monitoring performance of suppliers at Group level as well as at Site level.
    • Coordinates with sites to ensure that Supplier Audits and performed on-time and efficiently.
  • Assures all vendors are appropriately evaluated and approved to consistently meet product requirements
  • Monitoring performance of suppliers at Group level as well as at Site level.
  • Responsible for the management of the global supplier management process ensuring compliance to FDA, European, Corporate, and other international regulatory bodies regulations.

Distribution agreement
  • Manage and lead the coordination of Global Agreements, including Distribution partners, Suppliers, and inter-site agreements.
  • Works to consolidate agreements with Distributors and Suppliers to where possible, reduce the total number of agreements for improved communication and clarity with our distribution and supplier partners.

Design Control and Technical Files
  • Manages QMS for the global Design Control and Technical File processes to ensure that the process is standardized for the New Product Development, while helping to ensure that the processes are compliant and lean which leads to on-time product launches with high quality products.

Regulatory Compliance
  • Manages global International Product Regulatory (IPR) Compliance process and KPIs to ensure that registrations are appropriately prioritized and submitted to meet business needs.

Other
  • Other duties as assigned
  • Manages personnel within group with responsibilities to include staffing, performance management, development and coaching, training, and application of policies, programs, and procedures. Assures that a positive employee relations environment is maintained through effective communication.
  • Implement appropriate controls to ensure all group records are maintained/archived to meet applicable record retention requirements. For specific records, ensure that information is available at a Group level or at Site level.
  • Prepares and submits periodic reports, as required.
  • Interacts with all departments and levels.
  • Assures that the duties, responsibilities, and authority of each job in his/her Department or area of influence are clearly defined and effectively communicated to incumbents.

Typical Background:

  • 5+ years in a leadership role in quality/regulatory in life sciences, preferably in medical devices.
  • Lead Auditor through an accredited course
  • Bachelor’s Degree or equivalent in science or engineering - required

Key Required Skills, Knowledge, and Capabilities
  • Strong sense of team and fair play
  • Ability to drive cross functional teams.
  • Conflict resolution skills in complex management organization
  • Strong relationship building skills
  • Proven track record of Quality execution including strategy and metrics
  • Must be creative; inquisitive
  • Must be culturally sensitive
  • Ability to work effectively through influence and relationships
  • Demonstrated experience with Project Management
  • High level of personal accountability

The salary for this remote role is between $100,000 and $130,000. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location.

#LI-BM1


Dentsply Sirona is an Equal Opportunity/ Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in Dentsply Sirona.
If you need assistance with completing the online application due to a disability, please send an accommodation request to [email protected]. Please be sure to include “Accommodation Request” in the subject.

For California Residents:

We may collect the following categories of personal information in connection with the submission of your resume or application materials to us for employment, and if hired, your employment with us: identifiers (e.g., name, address, email address, birthdate); personal records (e.g., telephone number, signature, education information, criminal background information, passport number and visa information); consumer characteristics (e.g., sex, marital status, veteran status, race, disability, sexual orientation); professional or employment information (e.g., resume, cover letter, employment history, background check forms, references, certifications, transcripts and languages spoken); and inferences from personal information collected (e.g., a profile reflecting abilities and aptitudes).

The above categories of personal information are collected for the following business purposes: performing recruitment and hiring services; processing interactions and transactions (e.g., to comply with federal and state laws requiring us to maintain certain records, managing the workforce); and security (e.g., detecting security incidents, protecting against fraudulent or illegal activity).

For additional details and questions, contact us at [email protected]