Innova Solutions

Description

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

As Quality Assurance Senior Specialist

,

You Will

Job Description

Specific responsibilities include but are not limited to:

• 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 Medical Devices, FDA Combination Product Regulation, ISO:13845, EU Medical Device Directive, EN 60601 and IEC/EN 62304)
• Experience supporting pre-clinical, clinical research, and/or pharmacovigilance activities
• Experience with risk-based Supplier Quality Management process
• Management of Global Inspection and Audit programs
• Experience in project 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.

We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines.

ASK ME HOW: .

Thank you! Harish Yadav

Phone: 213-797-4030

[email protected]

PAY Range AND 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

Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving 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).

About Innova Solutions

Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions

• Named One of America's Best Employers for New Grads by Forbes (2024
• Named One of the Best Companies to Work for by U.S. News & World Report (Private Companies List, 2024-2025)
• One of the Largest IT Staffing Firms in the US - Ranked #3 by Staffing Industry Analysts (SIA, 2024)
• One of the Largest Staffing Firms in the US - Ranked #13 by Staffing Industry Analysts (SIA, 2024; includes Innova Solutions, Volt, & HireGenics)
• Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023)
• One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC, 2024)
• AWS Advanced Tier Services Partner with 100+ certifications

Website

https: //www.innovasolutions.com/

Innova Solutions offers a referral bonus for qualified Ambassadors who refer eligible referrals. Submit referrals at https://innovasolutions.workllama.com/atsuser/anonreferafriend and earn $250-$1,000 per referral.

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 [email protected] 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.