Full Job Description
Innova Solutions has a client that is immediately hiring for a QA Complaint Specialist I
Position type: Full time Contract
Duration: Duluth, GA
Location: 6 months
As a(n) QA Complaint Specialist I you will:
The QA Complaint Specialist I independently conducts investigations into NAT assay related complaints, leads CAPA investigations, and performs work related to their area of expertise.
This role also maintains laboratory equipment and runs Panther assays to confirm/investigate customer complaints, supports QA validation studies and performs data analysis of test results.
* QA review of complaints
* Responsible for running assays to confirm/investigate customer complaints and supports QA validation studies.
* Provides feedback to Mfg/R&D on potential product improvements, product defects, and safety evaluations.
* Independently conducts complaint investigation through interfacing with field reps to acknowledge, document, analyze information and data and perform deeper investigation into root causes.
* Coordinates obtaining detailed information and return of affected material to support complaint investigation
* Conducts review of QC data and Non-Conformance reports
* Drafts investigation reports to support final closure of complaints and submits for review and approval
* Applies knowledge of medical device regulatory requirements to support the reporting decision process and identify reportable events within short timeframes
* Device History Records Review: Conducts review of DHR documentation including but not limited to batch records
* Leads CAPA investigations
* Maintains laboratory equipment in a calibrated state and completes necessary documentation
* Performs data analysis of test results
* Provide Feedback to Mfg/R&D to Improve Quality: Partners across functionally with internal departments to share feedback on potential product improvements, product defects, and safety evaluations
* Assists in Audit preparation as needed
* Completes training in a timely manner.
* Maintains training records
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!
SWEEKRITI KESHARI
(+1) 213-929-5182
Sweekriti.Keshari@innovasolutions.com
skeshari@acsicorp.com
PAY RANGE AND BENEFITS:
Pay Range*: $35 - $38 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:
Website: https://www.innovasolutions.com/
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 hr@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.
''
Position type: Full time Contract
Duration: Duluth, GA
Location: 6 months
As a(n) QA Complaint Specialist I you will:
The QA Complaint Specialist I independently conducts investigations into NAT assay related complaints, leads CAPA investigations, and performs work related to their area of expertise.
This role also maintains laboratory equipment and runs Panther assays to confirm/investigate customer complaints, supports QA validation studies and performs data analysis of test results.
* QA review of complaints
* Responsible for running assays to confirm/investigate customer complaints and supports QA validation studies.
* Provides feedback to Mfg/R&D on potential product improvements, product defects, and safety evaluations.
* Independently conducts complaint investigation through interfacing with field reps to acknowledge, document, analyze information and data and perform deeper investigation into root causes.
* Coordinates obtaining detailed information and return of affected material to support complaint investigation
* Conducts review of QC data and Non-Conformance reports
* Drafts investigation reports to support final closure of complaints and submits for review and approval
* Applies knowledge of medical device regulatory requirements to support the reporting decision process and identify reportable events within short timeframes
* Device History Records Review: Conducts review of DHR documentation including but not limited to batch records
* Leads CAPA investigations
* Maintains laboratory equipment in a calibrated state and completes necessary documentation
* Performs data analysis of test results
* Provide Feedback to Mfg/R&D to Improve Quality: Partners across functionally with internal departments to share feedback on potential product improvements, product defects, and safety evaluations
* Assists in Audit preparation as needed
* Completes training in a timely manner.
* Maintains training records
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!
SWEEKRITI KESHARI
(+1) 213-929-5182
Sweekriti.Keshari@innovasolutions.com
skeshari@acsicorp.com
PAY RANGE AND BENEFITS:
Pay Range*: $35 - $38 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 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 hr@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.
''
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