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Bernie Silvers Email & Phone Number
Senior Quality Consultant
at
Independent Consultant
1 work email found
@smiledirectclub.com
2 phones found area 512
LinkedIn matched
✓ Verified Jun 2026
4 data sources
Profile completeness 100%
Current company
Role
Senior Quality Consultant
Location
Nashville, Tennessee, United States
Company size
Who is Bernie Silvers? Overview
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Quick answer
Bernie Silvers is listed as Senior Quality Consultant at Independent Consultant, a company with 7537 employees, based in Nashville, Tennessee, United States. AeroLeads shows a work email signal at smiledirectclub.com, phone signal with area code 512, and a matched LinkedIn profile for Bernie Silvers.
Bernie Silvers previously worked as Senior Quality Consultant at Prp Compliance and Senior Director, Quality at Smiledirectclub. Bernie Silvers holds Bs, Divisional Science, Biology/Biological Sciences, General from Sterling College.
Company email context
Email format at Independent Consultant
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{first}.{last}@smiledirectclub.com
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AeroLeads found 1 current-domain work email signal for Bernie Silvers. Compare company email patterns before reaching out.
Profile bio
About Bernie Silvers
Proven quality professional with a track record of success in building FDA regulated Quality Systems within challenging and leading edge industries. Passionate about building a Quality System with the ability to exceed both internal and external customer and business requirements. Strategic thinker who combines visionary ideas with demonstrable results in both national and international markets. Significantly increased the levels of service in the organization, while managing reductions in resources. Utilizes proven flexible and innovative techniques in complying with QSR and ISO requirements. Tactical problem solver focused on building quality into procedures and processes within all levels of an organization.Specialties:•Total Quality Management • Project and Process Management • cGMP/cGLP/GCP regulations • Design Control • ISO 13485 / 14971 guidelines • CE IVD Directive • Change Management • Operations management • Team Cross-Functional Training and Development • • Strategic Planning • Coaching and Training
Listed skills include Quality System, Gmp, Quality Assurance, Fda, and 45 others.
Current workplace
Bernie Silvers's current company
Company context helps verify the profile and gives searchers a useful next step.
Independent Consultant
12 roles · 23 years
Bernie Silvers work experience
A career timeline built from the work history available for this profile.
Senior Quality Consultant
Current- Develop and implement an ISO compliant quality management system.
- Prepare team for the successful completion of ISO certification audit, ensuring adherence to international quality standards.
- Collaborate with R&D, manufacturing, engineering, and regulatory affairs teams to ensure product development and manufacturing processes are aligned with quality objectives and standards.
- Establish risk management processes, including identification, assessment, and mitigation strategies for enhanced product safety and reduction of risks.
- Implement internal audit program to monitor quality management system compliance.
- Implement comprehensive quality training programs to enhance employees' understanding of quality standards, procedures, and regulations.
Sep 2022 - Present
Senior Director, Quality
- Provide Quality leadership and set the quality standard for the expanding manufacturing site and organization.
- Responsible for setting the overall strategies, tactics and directions of the site QA, Quality Operations, Quality Systems and Quality Design and Development departments.
- Hold final accountability for and decision making on the matters relating to GMP compliance for the site in alignment with Senior Leadership.
- Ensure that the site goals and objectives are accomplished.
- Identify continuous improvement opportunities for the quality systems including complaint analysis, quality investigations, CAPA, supplier quality and change control.
- Establish and implement quality metrics for monitoring system effectiveness and to enable the company team to make sound quality decisions and monitor continuous quality improvement.
Sep 2020 - Jun 2022
Director, Quality Systems
- Serve as the ADL and SDC expert on quality management systems and compliance, ensuring sites are supported through the implementation and effectiveness activities.
- Design, establish, implement, and maintain a resource plan that fully supports the needs of the business to maintain a compliant QMS
- Lead move from paper based QMS and through implementation of eQMS (MasterControl)
- Serve as Management Rep in facility, host for Internal and External audits (FDA, ISO)
- Lead and oversee the change management, CAPA, QMR, internal audit, and training functions for the organization.
- Function as the Subject Matter Expert on the quality management system, change control, internal audits, and CAPA during external audits/inspections by regulatory authorities (i.e. Notified Bodies, FDA, etc.).
Sep 2019 - Sep 2020
Senior Manager, Quality Assurance
Develop and implement a Quality System for ISO 13485:2016 certification, implement a robust Design Control process to support the launch of CE-IVD products, manage the day to day execution of quality systems, build and foster a culture of Quality in a previously R&D/RUO environment, and continually improve and build on the quality system while maintaining.
Apr 2017 - Sep 2019
Director, Us Quality Affairs
Responsible for the implementation and management/oversight of the quality assurance and quality improvement programs. Ensure that processes and standards comply with all relevant quality standards and regulations; conduct continuous improvement reviews/audits with regards to all relevant policies/procedures and implements corrective action as.
Jul 2016 - Mar 2017
Director, Us Quality Affairs
Responsible for the implementation and management/oversight of the quality assurance and quality improvement programs. Ensure that processes and standards comply with all relevant quality standards and regulations; conduct continuous improvement reviews/audits with regards to all relevant policies/procedures and implements corrective action as.
May 2015 - Jul 2016
Director Of Quality Assurance And Regulatory Affairs
Develop and implement regulatory strategies in support of new product development, lead the company’s discussions with all external agencies, manage the day to day execution of quality systems and implements improvements to the quality system while maintaining compliance with applicable Quality System Regulations and ISO standards (13485 and QSR), lead and.
Dec 2012 - May 2015
Supplier Quality Engineer
Nov 2011 - Dec 2012
Manager Of Quality Assurance
Mystic Pharmaceuticals, Inc.
Mar 2009 - Oct 2011
Quality System Specialist
Oct 2006 - Mar 2009
Qa Product Specialist
2003 - 2006
~3 yrs
1 education record
Bernie Silvers education
-
Sterling College
FAQ
Frequently asked questions about Bernie Silvers
Quick answers generated from the profile data available on this page.
What company does Bernie Silvers work for?
Bernie Silvers works for Independent Consultant.
What is Bernie Silvers's role at Independent Consultant?
Bernie Silvers is listed as Senior Quality Consultant at Independent Consultant.
What is Bernie Silvers's email address?
AeroLeads has found 1 work email signal at @smiledirectclub.com for Bernie Silvers at Independent Consultant.
What is Bernie Silvers's phone number?
AeroLeads has found 2 phone signal(s) with area code 512 for Bernie Silvers at Independent Consultant.
Where is Bernie Silvers based?
Bernie Silvers is based in Nashville, Tennessee, United States while working with Independent Consultant.
What companies has Bernie Silvers worked for?
Bernie Silvers has worked for Independent Consultant, Prp Compliance, Smiledirectclub, Perkinelmer, Inc., and Zimmer Biomet (Formerly Ldr).
How can I contact Bernie Silvers?
You can use AeroLeads to view verified contact signals for Bernie Silvers at Independent Consultant, including work email, phone, and LinkedIn data when available.
What schools did Bernie Silvers attend?
Bernie Silvers holds Bs, Divisional Science, Biology/Biological Sciences, General from Sterling College.
What skills is Bernie Silvers known for?
Bernie Silvers is listed with skills including Quality System, Gmp, Quality Assurance, Fda, Medical Devices, Iso 13485, Quality Auditing, and Capa.
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