Quality Engineering, Advanced / Quality Assurance Specialist
About The Position
Volt is immediately hiring for Quality Assurance Specialist in Cedar Creek, Texas. As a Quality Assurance Specialist, you will drive quality assurance activities related to batch review, change control, NCRs, Deviations, CAPAs, Audits, and support Product Complaints technical investigations for the relevant product platforms. You will also support 3rd party audit of the site through audit prep and participating in the front/back room. Apply advanced Quality Assurance and Scientific Method techniques and principles to daily tasks and activities. Apply relevant regulations, standards, GxP requirements, and industry best practices to assignments. Plan and conduct projects and activities with moderate to high technical responsibility, complexity, and strategic feedback. Act as an SME in quality assurance and scientific matters as applicable. Develop and drive key strategic quality assurance initiatives throughout the organization. Contribute to the development of new projects/programs/processes. Lead/drive root cause investigations for multiple issues, including complaints, NCRs, Deviations, OOS, etc. Lead projects requiring representation of the organization to internal and/or external customers or others, providing expertise and promoting solutions.
Requirements
- Bachelor’s or master’s Degree in biology, chemistry, biotechnology, engineering, or a related field, or equivalent experience.
- 4+ years of experience in a similar position within the Life science industry.
- Familiarity with medical device regulations, such as ISO 13485, FDA 21 CFR part 820, and IVDR 2017/746 is required.
- Strong organizational and analytical skills with a focus on finding effective and efficient solutions in compliance with the regulations.
Nice To Haves
- Post-graduate, Quality Assurance Certifications, such as Six Sigma, CQA, etc., is preferred.
Responsibilities
- Drives quality assurance activities related to batch review, change control, NCRs, Deviations, CAPAs, Audits, and supports Product Complaints technical investigations for the relevant product platforms.
- Support 3rd party audit of site through audit prep and participating in the front/back room.
- Apply advanced Quality Assurance and Scientific Method techniques and principles to daily tasks and activities.
- Apply relevant regulations, standards, GxP requirements, and industry best practices to assignments.
- Plan and conduct projects and activities with moderate to high technical responsibility, complexity, and strategic feedback.
- Act as an SME in quality assurance and scientific matters as applicable.
- Develop and drive key strategic quality assurance initiatives throughout the organization.
- Contributes to the development of new projects/programs/processes.
- Lead/drive root cause investigations for multiple issues, including complaints, NCRs, Deviations, OOS, etc.
- Leads projects requiring representation of the organization to internal and/or external customers or others, providing expertise and promoting solutions.
Benefits
- health
- dental
- vision
- term life
- short term disability
- AD&D
- 401(k)
- Sick time
- other types of paid leaves (as required by law)
- Employee Assistance Program (EAP)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
