Innova Solutions
Quality Assurance Senior Specialist
Innova Solutions, Thousand Oaks, California, United States, 91362
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A client of Innova Solutions is immediately hiring for a Quality Assurance Senior Specialist
Position type:
Full-time– Contract Duration:
12 Months Location:
Thousand Oaks, CA
Responsibilities
Manage the collaboration on the process improvement, transfer and sustainment of QMS processes, across client's Operations and R&D, to the Digital QMS platform for health and control processes.
Leads Digital QMS audit & inspection readiness, deviations and change control activities
Manage Organizational Change Management (OCM) activities and Training deliverables that support the Digital QMS
Maintain knowledge of current systems, tools, standard methodologies, and terminology and ensure adherence to GxP (GMP, GDP, GCP, GLP & GPvP) and other applicable regulations
Manages and provides oversight of documents / records within the Quality Management System
Oversight of process key performance indicators and metrics
Manages external contractors providing services to the Digital QMS
Working across teams managing priorities
Preferred Qualifications
Strong Knowledge and experience in Medical Device Quality System Regulations and Medical Device Standards
Previous experience managing implementation of Quality Management System Requirements, Product Standards / Regulatory Requirements (e.g. FDA CFRs for Biologics and MedicalDevices, FDA Combination Product Regulation, ISO:13845, EU Medical Device Directive, EN 60601 and IEC/EN 62304)
Experiencesupporting pre-clinical, clinical research, and/or pharmacovigilance activities
Experiencewith risk-based Supplier Quality Management process
Managementof Global Inspection and Audit programs
Experience inproject management, process improvement and quality system management
Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
Benefits Pay Range*: $34.00-$38.00 per hour. *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Benefits: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health savings account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
Equal Opportunity & EEO Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at athr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.
Harish Yadav Phone: 213-797-4030 harish.yadav@innovasolutions.com
#J-18808-Ljbffr
Get AI-powered advice on this job and more exclusive features.
Sign in to access AI-powered advices Continue with Google
A client of Innova Solutions is immediately hiring for a Quality Assurance Senior Specialist
Position type:
Full-time– Contract Duration:
12 Months Location:
Thousand Oaks, CA
Responsibilities
Manage the collaboration on the process improvement, transfer and sustainment of QMS processes, across client's Operations and R&D, to the Digital QMS platform for health and control processes.
Leads Digital QMS audit & inspection readiness, deviations and change control activities
Manage Organizational Change Management (OCM) activities and Training deliverables that support the Digital QMS
Maintain knowledge of current systems, tools, standard methodologies, and terminology and ensure adherence to GxP (GMP, GDP, GCP, GLP & GPvP) and other applicable regulations
Manages and provides oversight of documents / records within the Quality Management System
Oversight of process key performance indicators and metrics
Manages external contractors providing services to the Digital QMS
Working across teams managing priorities
Preferred Qualifications
Strong Knowledge and experience in Medical Device Quality System Regulations and Medical Device Standards
Previous experience managing implementation of Quality Management System Requirements, Product Standards / Regulatory Requirements (e.g. FDA CFRs for Biologics and MedicalDevices, FDA Combination Product Regulation, ISO:13845, EU Medical Device Directive, EN 60601 and IEC/EN 62304)
Experiencesupporting pre-clinical, clinical research, and/or pharmacovigilance activities
Experiencewith risk-based Supplier Quality Management process
Managementof Global Inspection and Audit programs
Experience inproject management, process improvement and quality system management
Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
Benefits Pay Range*: $34.00-$38.00 per hour. *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Benefits: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health savings account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
Equal Opportunity & EEO Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at athr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.
Harish Yadav Phone: 213-797-4030 harish.yadav@innovasolutions.com
#J-18808-Ljbffr