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. This position is located in York, Pennsylvania. Offering the cultural attractions of a big city and the down-home charm of a small town, York, PA is an extraordinary place to live, work and play. York is located in south-central Pennsylvania and is within 25 miles of Gettysburg and Lancaster, 45 miles of Baltimore and Hershey, and 100 miles of Washington, DC and Philadelphia. Engrained with a rich history and heritage and becoming one of the fastest growing cities in Pennsylvania, York is a place where the past and the present comfortably coexist.
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 Scope:Under general direction, this position is responsible for leading and guiding the various aspects of the Quality Assurance systems, including internal / external audits, corrective and preventive actions, document control, change control, non-conformance, QA test lab, calibration and complaint handling.
Responsibilities:Manage multiple Quality Assurance systems within the division. Within assigned systems, lead compliance efforts, review and maintain documentation and develop action plans. As a quality system expert, identify and recommend opportunities for improvement within process. Update SOPs as necessary. Process may include, but are not limited to:
- Internal / External Audits
- SDS Management
- Document Control
- LMS (Learning Management Systems)
- Assure the ongoing compliance of the SBU by identifying and correcting gaps in procedures and designing and presenting training programs to educate associates at all levels within the Division.
- Facilitate and/or attend appropriate team meetings related to assigned quality systems (i.e. COC, CRB, MRB, PSC).
- Develop and prepare reporting related to assigned systems.
- Effectively collaborate with resources that may or may not be directly under their control to achieve both individual and team goals.
- Ensure technical writing across the organization meets the necessary requirements/standards & educate associates as necessary.
- All other duties as assigned.
Education: - High school diploma or GED required.
- Associate's or Bachelor's Degree in Quality Assurance, Regulatory Affairs or related field a plus.
Certifications/Licensing: - Professional certification in Quality Assurance, Regulatory Affairs or Lean Six Sigma preferred but not required.
Years and Type of Experience: - 1 to 5 year's experience in a quality and/or regulatory affairs role in a regulated manufacturing environment preferred, medical device manufacturing experience a plus.
Key Required Skills, Knowledge and Capabilities: - Good understanding of cGMP, ISO 9000/9001/13485 and FDA Quality Systems.
- Strong computer skills with knowledge of Microsoft Office Suite (Word, Excel, Access and PowerPoint), e-mail and Internet.
- Excellent communication skills - written and verbal.
- Interpersonal skills to include customer-focused orientation with both internal and external customers.
- Strong decision-making skills, ability to work independently with minimal supervision.
- Comprehensive organization and analytical skills.
- Customer focused orientation with internal and external customers.
Key Behaviors Critical for Success in this Role:Here at Dentsply Sirona, our vision is to transform dentistry to improve oral health globally.Every day, we empower millions of customers by proudly creating innovative solutions for healthy smiles.
Our Operating Principles guide our daily activities: - We approach customers as ONE company, and they are the core of everything we do.
- We create innovative solutions that customers love to use.
- We think and act with positive intent and the highest integrity.
- We operate sustainably in everything we do.
- We use our size and global breadth to our advantage.
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]