Company name: Dentsply Sirona
Type of industry, product or service: Medical Devices – Dentistry Products and Services
Job Title: Quality Compliance Manager
Location: Charlotte, NC (or potentially remote)
- Chester High (QA Training Manager)
- Phone: 216-925-3975
- Email: Chester.High@DentsplySirona.com
Requirements and Qualifications:
The Quality Compliance Manager will ensure compliance with cGMP, regulatory and internal requirements regarding the manufacturing, testing and distributing of products through audits, investigations, training and recommendations to procedures. Ensure internal site compliance to applicable regulations, standards and quality systems and through direct interactions with the QA/RC Groups/Locations and periodic auditing. Establish guidelines and requirements for quality and regulatory compliance in supporting special projects and ongoing operations. Act as liaison/Subject Matter Expert to establish best practices across the various Groups/Locations.
- Assures the Dentsply Sirona’s quality system complies with applicable regulatory requirements and the Product Groups have adopted the Corporate Quality System, as applicable.
- Establishes new or improves existing infrastructure to achieve conformance to the CFR 820, ISO 13485, EU MDR, cGMP QS Regulation as well as FDA’s new auditing techniques.
- Plans and executes the whole internal quality audit activities from start to end.
- Follows-up on audit findings for internal and external audits.
- Manage the tracking, reporting, positioning, adequacy of actions, verification, closeout, and trending of all corrective and preventive actions for all audits performed.
- Prepare for Internal assessments by researching background information, including previous audit results.
- Perform the audit / assessment by collecting and analyzing objective evidence regarding issues and risks. Report findings to management team.
- Evaluate corrective and preventive action responses to the assessment findings for adequacy, including root cause and timeliness. Communicate issues to management team.
- Manage the assessment file through the process to closure.
- Perform follow-up audits to confirm corrective and preventive action is effective.
- Remain current in regulatory knowledge through attendance at related conferences, seminars, meetings, and other training methods such as independent study of periodicals, Internet or other literature.
- Support and participate with management during external regulatory inspections as needed.
- Prepares management reports depicting trends for management review purposes.
- Participate in continuous improvement initiatives.
- Bachelor’s degree required, Master’s degree preferred.
- 8-10 years related experience required.
- 50-60% business travel required.
- Excellent oral and technical writing skills with the ability to interface effectively cross-functionally and at all levels.
- Demonstrate leadership and organization skills.
- ASQ Auditor Certification or ISO lead auditor certification preferred.
- Knowledge of applicable FDA and international standards/regulations including ISO 13485, 21 CFR 820, EU MDR, and EU MDD.
- Analytical skills and ability to apply statistics and metrics to process improvement models.
- Extensive working knowledge of applicable quality and regulatory standards and regulations.
- Work effectively, independently and in team environment.
- Must demonstrate sound judgment and analytical skills to enable assessment of risk.
- Good working knowledge of Windows based applications.
- Resourceful, self-reliant, self-motivated and confident.
- Working knowledge of quality software system (e.g. SmartSolve)