Senior Quality Assurance Manager

HealthFirst - Saving Lives•Mukilteo, WA

About The Position

Manage the quality function and lead resolution of quality and compliance issues. Ensure that the quality management system is efficient, effectively implemented, and compliant with the requirements of applicable regulations and the respective agencies, including the US Food & Drug Administration (FDA), National Association of Boards of Pharmacy (NABP), and Drug Enforcement Administration (DEA). Oversee the management of the device design process and pharmaceutical repackaging and relabeling, quality system record maintenance, writing/revising SOPs and manufacturing instructions, providing Good Manufacturing Practices (GMP)/ Quality System Regulation (QSR) and procedural training for employees, and managing critical quality management system processes within the Corrective and Preventative Action (CAPA), internal audit, document control, etc. Develop appropriate training and compliance awareness programs. Lead and manage the quality team to ensure compliance with applicable regulations, maintain high-quality standards, and achieve organizational objectives.

Requirements

Bachelor’s or foreign equivalent degree in Biomedical Engineering, Quality Management, Industrial Engineering, or closely related field, plus 5 years of progressive experience in position offered or related occupation performing quality assurance in a regulated environment in the drug distribution, medical device and/or pharmaceutical industry.
Must have 5 years of quality assurance experience in the drug distribution, medical device and/or pharmaceutical industry in: creating reports, business correspondence, and procedure manuals; developing and articulating risk analyses; working with regulations and guidance governing medical device manufacturing and/or healthcare distribution, including FDA 21 CFR requirements and ISO standards, including 13485 and 14971; working with FDA regulations, Good Manufacturing Practices; and working with manufacturing and/or distribution and auditing processes.
Must have 3 years of experience as a quality assurance supervisor or manager overseeing QA activities ensuring compliance in the manufacturing of medical products, and overseeing the development and maintenance of quality programs, systems, processes and procedures.
Travel for industry conferences within the U.S., 1-2 times per year for 3-4 days.
Travel to other sites within the US as needed to support onsite audits, 1x per year for 3-5 days.

Responsibilities

Manage the quality function and lead resolution of quality and compliance issues.
Ensure that the quality management system is efficient, effectively implemented, and compliant with the requirements of applicable regulations and the respective agencies, including the US Food & Drug Administration (FDA), National Association of Boards of Pharmacy (NABP), and Drug Enforcement Administration (DEA).
Oversee the management of the device design process and pharmaceutical repackaging and relabeling, quality system record maintenance, writing/revising SOPs and manufacturing instructions, providing Good Manufacturing Practices (GMP)/ Quality System Regulation (QSR) and procedural training for employees, and managing critical quality management system processes within the Corrective and Preventative Action (CAPA), internal audit, document control, etc.
Develop appropriate training and compliance awareness programs.
Lead and manage the quality team to ensure compliance with applicable regulations, maintain high-quality standards, and achieve organizational objectives.