What are the responsibilities and job description for the Clinical Quality Assurance Specialist position at MicroVention?
Job Title: Clinical Quality Assurance Specialist
Job Summary:
We are seeking a Clinical Quality Assurance Specialist to provide support to all aspects of the Clinical Quality Assurance function across the business. The successful candidate will work closely with CQA Management to assure quality throughout MicroVention and promote continual improvement processes to ensure all systems and procedures are compliant with Standard Operating Procedures (SOPs), regulations, standards, good clinical practices, and guidelines applicable to the medical device industry.
Key Responsibilities:
* Conduct clinical research audits (sponsor, site, vendor, process, function, and systems)
* Prepare for and host external regulatory inspections (e.g., mock BIMO, BIMO, for cause, etc.)
* Plan, execute, report, root cause analysis investigation, and closure
* Provide comprehensive compliance direction to clinical study teams and cross-functional partners
* Ensure clinical studies are conducted to the highest ethical and safety standards
Requirements:
* Bachelor's degree in life sciences or related field
* Minimum of four (4) years of experience in clinical research and/or GCP related QA environment including auditing and/or external inspections (e.g., BIMO)
* Minimum of two (2) years project management skills, including the ability to develop, prioritize and manage project plans and approaches for global efforts
* In-depth understanding of global regulations and/or standards governing the conduct of clinical studies (e.g., 21 Code of Federal Regulations (CFR) Parts 11, 50, 54, 56, 812, 814, 820 and International Organization for Standardization (ISO) 14155 and 13485)
* Advanced working knowledge of QA principles including Quality Risk Management (QRM), Critical Thinking, and Quality by Design (QbD)
* Strong knowledge of compliance risks and quality controls
* Experience in adult education and/or training clinical research personnel
* Investigational medical device and/or neurovascular experience
* Ability to concisely interpret clinical study results, safety reporting, data integrity, and metrics
* Advanced skills in strategic thinking, evaluating, and solving issues with varying degrees of complexity and ability to provide meaningful analysis output, recommendations, and information delivery to management
* Agile mindset and flexibility to meet changing needs and requirements for audit and/or inspections schedule
* Demonstrate strong commitment to compliance, ethics, and accountability
* Strong verbal and written communication skills, including strong technical writing skills
* Proficient MS Office skills to include Word, PowerPoint, Excel, and Teams
Job Summary:
We are seeking a Clinical Quality Assurance Specialist to provide support to all aspects of the Clinical Quality Assurance function across the business. The successful candidate will work closely with CQA Management to assure quality throughout MicroVention and promote continual improvement processes to ensure all systems and procedures are compliant with Standard Operating Procedures (SOPs), regulations, standards, good clinical practices, and guidelines applicable to the medical device industry.
Key Responsibilities:
* Conduct clinical research audits (sponsor, site, vendor, process, function, and systems)
* Prepare for and host external regulatory inspections (e.g., mock BIMO, BIMO, for cause, etc.)
* Plan, execute, report, root cause analysis investigation, and closure
* Provide comprehensive compliance direction to clinical study teams and cross-functional partners
* Ensure clinical studies are conducted to the highest ethical and safety standards
Requirements:
* Bachelor's degree in life sciences or related field
* Minimum of four (4) years of experience in clinical research and/or GCP related QA environment including auditing and/or external inspections (e.g., BIMO)
* Minimum of two (2) years project management skills, including the ability to develop, prioritize and manage project plans and approaches for global efforts
* In-depth understanding of global regulations and/or standards governing the conduct of clinical studies (e.g., 21 Code of Federal Regulations (CFR) Parts 11, 50, 54, 56, 812, 814, 820 and International Organization for Standardization (ISO) 14155 and 13485)
* Advanced working knowledge of QA principles including Quality Risk Management (QRM), Critical Thinking, and Quality by Design (QbD)
* Strong knowledge of compliance risks and quality controls
* Experience in adult education and/or training clinical research personnel
* Investigational medical device and/or neurovascular experience
* Ability to concisely interpret clinical study results, safety reporting, data integrity, and metrics
* Advanced skills in strategic thinking, evaluating, and solving issues with varying degrees of complexity and ability to provide meaningful analysis output, recommendations, and information delivery to management
* Agile mindset and flexibility to meet changing needs and requirements for audit and/or inspections schedule
* Demonstrate strong commitment to compliance, ethics, and accountability
* Strong verbal and written communication skills, including strong technical writing skills
* Proficient MS Office skills to include Word, PowerPoint, Excel, and Teams
