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, USA. 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.
Job Summary:
The QA Manager is responsible for development and implementation Quality system processes including supplier and internal audits, hosting audits of Dentsply Sirona North America at Lancaster Distribution Center(LDC) by regulatory agencies and corporate QA compliance team.
This position ensures that all related systems/procedures, etc. are in full compliance with quality compliance regulations and corporate quality policies applicable to order-to-delivery processes within the Lancaster Distribution Center and North America Distribution.
This position also has team management of the North America Hub & Spoke Distribution QA team based in the US and Canada.
Leads, motivates, and develops the quality team, clearly communicates expectations, and ensures staff is appropriately trained. Is responsible for the management of QA aspects in the business partner relationship with suppliers(e.g. 3PL companies).
Key Responsibilities:
Establishes, maintains, and continually evaluates the quality management system to ensure compliance with applicable regulations.
Works well cross-functionally to ensure full Group compliance with applicable requirements
Leads quality system activities within Distribution Quality Management System (QMS) in accordance with Dentsply Sirona policies, international standards, and regulatory requirements.
Ensures visibility of upcoming changes/activities that could potentially lead to process quality and regulatory risk.
Supports the implementation of a harmonized QMS across the Dentsply Sirona global distribution network.
Implements and maintains QMS to ensure the compliance with FDA regulations, Corporate QA/RA, and internal requirements.
Conducts/contracts internal self-assessment audits to identify and correct internal deviations.
Creates, implements, and maintains training metrics to ensure that FDA and ISO13485 requirements are followed with discipline.
Conducts SOP training effectiveness to ensure that each employee follow internal Quality System processes, internal SOPs
and their job descriptions.
Works collaboratively with all departments to implement corrective action and minimize GMP and Quality System regulatory deviations.
Works closely with Operations, Manufacturers, Sales, and Customer Service to ensure awareness of any non-conformities.
Communicates quickly any information regarding delays, holds, recalls.
Reviews audits deviations and corrective actions of Corporate, FDA and internal inspections with the group leadership team.
Conducts/coordinates annual and new employee Quality Awareness GMP and SOP employee training.
Assists in obtaining and maintaining of the necessary site licenses for our facility
Acts as the LDC Designated Representative for state licenses
Develops strategic initiatives with all GBUs to drive quality compliance continuous improvement, to reduce deviations and to increase level of compliance.
Responsible for managing LDC RSMP and annual FDA establishment registration and device listing renewals
Manages the performance and development of direct reports.
Provides vision and leadership by establishing annual departmental goals and objectives for each area of responsibility in line with the short and long term vision of the company.
Delegates work that actively promotes and supports employee growth and development.
Effectively manages staff performance through establishing and communicating performance standards and accurate job descriptions.
Ensures periodic review and update of job descriptions as the business and job functions evolve.
Establishes for him/herself and ensure the development of individual performance objectives for direct reports within set timelines (tying into department, group, and company objectives).
Provides frequent and ongoing feedback sessions to ensure established standards are maintained.
Recruits, develops, and trains personnel through effective utilization of policies and processes.
Maximizes employee development through accurate evaluation of talent and mutual development of effective Individual Development Plans and subsequent frequent feedback sessions.
Performs other duties as assigned or as may be necessary
Education:
Bachelors Degree in Science, related technical field or equivalent.
Certifications/Licensing:
Valid driver?s license is required
Years and Type of Experience:
Min. 5 years quality assurance, regulatory relevant experience in medical device or pharmaceutical industries
Key Required Skills, Knowledge, and Capabilities:
Demonstrated success in achieving/exceeding sales results
Ability to work well within a team environment
Results oriented and highly self-motivated
Able to strike a proper balance between catalyst for change and team player
Sound risk management decision-making
Critical and analytical problem solving skills
Strong ability to multi-task and juggle various projects effectively
Adaptability to changing demands and conditions
Excellent organizational and time management skills
Strong interpersonal skills
Strong written and verbal communication skills
Strong computer skills
Knowledge/experience in an ISO setting
Manufacturing experience
Working knowledge of FDA requirements
Positive ?can do? professional attitude.
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 careers@dentsplysirona.com (careers@dentsply.com) . Please be sure to include ?Accommodation Request? in the subject.
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.
Job Summary:
The QA Manager is responsible for development and implementation Quality system processes including supplier and internal audits, hosting audits of Dentsply Sirona North America at Lancaster Distribution Center(LDC) by regulatory agencies and corporate QA compliance team.
This position ensures that all related systems/procedures, etc. are in full compliance with quality compliance regulations and corporate quality policies applicable to order-to-delivery processes within the Lancaster Distribution Center and North America Distribution.
This position also has team management of the North America Hub & Spoke Distribution QA team based in the US and Canada.
Leads, motivates, and develops the quality team, clearly communicates expectations, and ensures staff is appropriately trained. Is responsible for the management of QA aspects in the business partner relationship with suppliers(e.g. 3PL companies).
Key Responsibilities:
Establishes, maintains, and continually evaluates the quality management system to ensure compliance with applicable regulations.
Works well cross-functionally to ensure full Group compliance with applicable requirements
Leads quality system activities within Distribution Quality Management System (QMS) in accordance with Dentsply Sirona policies, international standards, and regulatory requirements.
Ensures visibility of upcoming changes/activities that could potentially lead to process quality and regulatory risk.
Supports the implementation of a harmonized QMS across the Dentsply Sirona global distribution network.
Implements and maintains QMS to ensure the compliance with FDA regulations, Corporate QA/RA, and internal requirements.
Conducts/contracts internal self-assessment audits to identify and correct internal deviations.
Creates, implements, and maintains training metrics to ensure that FDA and ISO13485 requirements are followed with discipline.
Conducts SOP training effectiveness to ensure that each employee follow internal Quality System processes, internal SOPs
and their job descriptions.
Works collaboratively with all departments to implement corrective action and minimize GMP and Quality System regulatory deviations.
Works closely with Operations, Manufacturers, Sales, and Customer Service to ensure awareness of any non-conformities.
Communicates quickly any information regarding delays, holds, recalls.
Reviews audits deviations and corrective actions of Corporate, FDA and internal inspections with the group leadership team.
Conducts/coordinates annual and new employee Quality Awareness GMP and SOP employee training.
Assists in obtaining and maintaining of the necessary site licenses for our facility
Acts as the LDC Designated Representative for state licenses
Develops strategic initiatives with all GBUs to drive quality compliance continuous improvement, to reduce deviations and to increase level of compliance.
Responsible for managing LDC RSMP and annual FDA establishment registration and device listing renewals
Manages the performance and development of direct reports.
Provides vision and leadership by establishing annual departmental goals and objectives for each area of responsibility in line with the short and long term vision of the company.
Delegates work that actively promotes and supports employee growth and development.
Effectively manages staff performance through establishing and communicating performance standards and accurate job descriptions.
Ensures periodic review and update of job descriptions as the business and job functions evolve.
Establishes for him/herself and ensure the development of individual performance objectives for direct reports within set timelines (tying into department, group, and company objectives).
Provides frequent and ongoing feedback sessions to ensure established standards are maintained.
Recruits, develops, and trains personnel through effective utilization of policies and processes.
Maximizes employee development through accurate evaluation of talent and mutual development of effective Individual Development Plans and subsequent frequent feedback sessions.
Performs other duties as assigned or as may be necessary
Education:
Bachelors Degree in Science, related technical field or equivalent.
Certifications/Licensing:
Valid driver?s license is required
Years and Type of Experience:
Min. 5 years quality assurance, regulatory relevant experience in medical device or pharmaceutical industries
Key Required Skills, Knowledge, and Capabilities:
Demonstrated success in achieving/exceeding sales results
Ability to work well within a team environment
Results oriented and highly self-motivated
Able to strike a proper balance between catalyst for change and team player
Sound risk management decision-making
Critical and analytical problem solving skills
Strong ability to multi-task and juggle various projects effectively
Adaptability to changing demands and conditions
Excellent organizational and time management skills
Strong interpersonal skills
Strong written and verbal communication skills
Strong computer skills
Knowledge/experience in an ISO setting
Manufacturing experience
Working knowledge of FDA requirements
Positive ?can do? professional attitude.
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 careers@dentsplysirona.com (careers@dentsply.com) . Please be sure to include ?Accommodation Request? in the subject.
Key skill Required
- Customer Service
- Manufacturing
- Quality Management
- Team Management
- Sales
- Adaptability
- Affirmative Action
- Assurance
- Awareness
- Business Partner Relationship
- Commitment
- Communication
- Compliance
- Comprehensive
- Dental Care
- Dentistry
- Development
- Discipline
- Distribution Network
- Effectiveness
- History
- Implementation
- Innovation
- International Standards
- Interpersonal Skills
- Leadership
- Management
- Medical Device
- Orientation
- Periodic Review
- Problem Solving
- Process Quality
- Professional Development
- Quality Assurance
- Quality Management System
- Regulatory Requirements
- Risk Management
- Science
- Shaping
- Strategic Initiatives
- Team Player
- Time Management
- Training
- Verbal Communication
- Written and Verbal Communication
- International
