Marlene Scoppettone
About Marlene Scoppettone
Marlene Scoppettone is a Quality Assurance Specialist with extensive experience in supplier audits and compliance within the medical device and manufacturing industries. She has held various positions in notable companies and has specialized training in sterilization validation.
Current Role at Toray Advanced Composites
Marlene Scoppettone serves as a Quality Assurance Specialist at Toray Advanced Composites, a position she has held since 2021. In this role, she is responsible for ensuring product quality and compliance with industry standards. Her expertise in quality assurance contributes to the company's commitment to delivering high-quality composite materials.
Previous Experience in Quality Assurance
Marlene has held various quality assurance roles throughout her career. She worked at Santa Cruz Nutritionals as a Quality Assurance Specialist II from 2011 to 2013, where she performed supplier audits under industry standards. Prior to that, she served as a Quality Specialist at NeuroLutions from 2019 to 2021 and as a QA Specialist at Fox Racing Shox from 2006 to 2010. Her experience spans multiple industries, including medical devices and manufacturing.
Education and Training
Marlene completed her General Education at Watsonville High School, earning her diploma in 1991. She has also pursued specialized training in sterilization validation for the medical device industry through an ASQ course. Additionally, she holds a RABQSA certification for ISO 9001:2008 Internal Auditor Training, emphasizing her commitment to quality management.
Audit and Compliance Expertise
Marlene has extensive experience in conducting internal and external supplier audits in accordance with industry standards such as AS9100:2009, ISO 9001:2008, ISO/TS 16949:2009, and ISO 13485. Her role as a Device History Record Administrator at a biomedical company involved ensuring compliance with FDA 21 CFR 820 and ISO 13485 standards, highlighting her proficiency in regulatory requirements.
Safety and Quality Management
In her previous roles, Marlene has demonstrated a strong focus on safety and quality management. While working at Intuitive Surgical, she acted as the Cal-OSHA Safety Officer, assisting the VP of Operations in meeting Cal-OSHA regulations. Her experience as a Quality Supervisor/QMS Systems Administrator at Plasma Ruggedized Solutions further showcases her leadership in quality management systems.