Mark Durivage has worked as a practitioner, educator and consultant. His Bachelor of Science in Computer Aided Machining from Sienna Heights University and Master’s of Science in Quality Management from Eastern Michigan University, have shaped Durivage into an educated businessman. Additionally, he has served an apprenticeship and is a journeyman mold maker. Durivage holds the following certifications: CQM/OE, CRE, CQE, CBA, CHA, CPGP, CSSBB, CSQP, CTBS, and RAC.
Durivage is involved in many professional organizations as a member and has held leadership positions including the ASQ Toledo Section, the ASQ Reliability Division, the ASQ Biomedical Division, and the ASQ Food, Drug, & Cosmetic Division.
Statement of Ethical Practices
Quality Systems Compliance LLC pursues all its activities with the highest commitment to the basic values and principles of ethical behavior and integrity. Quality Systems Compliance LLC’s reputation for integrity is based on strict adherence to high ethical standards, embracing open and honest relations between customers, certification bodies, and regulators.
Quality Systems Compliance LLC acts ethically with the highest standards of integrity and abides by the principles of lawful conduct in all business dealings. Quality Systems Compliance LLC does not condone or participate in illegal or unethical acts.
Vision Statement
Quality Systems Compliance LLC’s vision is to be recognized as the premier solutions leader in the quality industry.
Mission Statement
Quality Systems Compliance LLC’s mission is to provide our customers with superior services that will differentiate us from our competitors.
Quality Policy
Quality Systems Compliance LLC believes quality is consistently providing services which meet customer expectations. We accomplish this by monitoring certification and regulatory requirements and continually improving our abilities to ensure customers are compliant with applicable standards and regulations.
Human Rights Policies
Quality Systems Compliance LLC complies with all U.S. Department of Labor laws and the laws of individual states where the company operates.
Quality Systems Compliance LLC prohibits the use of any indentured or forced labor, slavery, or servitude.
Quality Systems Compliance LLC does not use child labor.
Quality Systems Compliance LLC supports the use of legitimate workplace apprenticeship, internship and similar programs.
Awards
Quality Systems Compliance named one of the Top Ten Medical Device Consulting Companies in 2019 by MedTech Outlook. Read Full Article
Certifications
Quality Systems Compliance, LLC is certified for implementing and maintaining a Quality Management System under ISO 9001:2015 and ISO 13485:2016. View the Certifications
Organizations
Member, Society of Reliability Engineers (SRE) –SRE was founded in 1966 in Buffalo, New York, with the intention of providing a forum for individuals of various organization to discuss mutual issues in the then new discipline of Reliability. From this humble start SRE has since become an international society with more than twenty chapters worldwide. The SRE and its chapters are not-for-profit, equal opportunity organization, providing member opportunities for professional development.
Member, Regulatory Affairs Professionals Society (RAPS) – RAPS offers the Regulatory Affairs Certification (RAC) which is the only globally recognized professional credential for those involved with the regulation of healthcare products. The RAC exam tests your regulatory knowledge, as well as your critical thinking ability, in four areas of regulatory practice. RAC professionals are today’s leaders—setting the bar high for industry knowledge, dynamic critical thinking ability and a commitment to ongoing education. Certification is obtained by passing a rigorous exam and maintained by acquiring continuing education credits within a three-year cycle.
Member, Association for the Advancement of Medical Instrumentation (AAMI) – AAMI is a nonprofit organization founded in 1967, is a unique alliance of more than 6,000 members from around the world united by one mission — to increase the understanding and beneficial use of medical instrumentation through effective standards and educational programs, and publications. AAMI is the primary source of consensus and timely information on medical instrumentation and technology.
Member, American Association of Tissue Banks (AATB) – AATB is a professional, non-profit, scientific and educational organization. It is the only national tissue banking organization in the United States, and its membership totals more than 100 accredited tissue banks and 1,000 individual members. These banks recover tissue from more than 30,000 donors and distribute in excess of two million allografts for more than one million tissue transplants performed annually in the U.S. The overwhelming majority of the human tissue distributed for these transplants comes from AATB-accredited tissue banks.
Links
https://www.linkedin.com/in/markdurivage
www.sre.org (Society of Reliability Engineers)
www.aami.org (Association for the Advancement
of Medical Instrumentation)
www.aatb.org (American Association of Tissue Banks)
www.raps.org (Regulatory Affairs Professional Society)
