Quality Engineering, Advanced / Quality Assurance Specialist

Volt; Bastrop (TX); On-site; USD 69,000 - 72,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Term life

Short-term disability

AD&D

401(k)

Sick time

Paid leaves

Employee Assistance Program

Job summary

Volt is hiring a Quality Assurance Specialist in Cedar Creek, Texas. You will drive QA activities related to batch reviews, change controls, NCRs, deviations, CAPAs, and audits, supporting product investigations.

The ideal candidate has a degree in life sciences or engineering, 4+ years in QA within the life sciences, and familiarity with ISO 13485, FDA 21 CFR 820, and IVDR 2017/746. This is a full-time contract position with competitive pay and benefits.

Qualifications

• Bachelor's or master's degree in biology, chemistry, biotechnology, engineering, or related field.
• Post-graduate QA certifications (e.g., Six Sigma, CQA) preferred.
• 4+ years in Life science QA roles.
• Familiarity with ISO 13485, FDA 21 CFR part 820, and IVDR 2017/746.
• Strong organizational and analytical skills.

Responsibilities

• Drive QA activities related to batch review, change control, NCRs, deviations, CAPAs, audits.
• Support third‑party audits and audit prep.
• Apply QA methods and regulatory principles to daily tasks.
• Lead root cause investigations for multiple quality issues.
• Develop and drive strategic QA initiatives.
• Represent the organization to customers as needed.

Skills

Quality Assurance

GxP compliance

Audits

Root cause analysis

Documentation

Regulatory knowledge

Education

Bachelor's/Master's degree in Life Sciences or Engineering

Job description

Build your future with Volt! Volt is immediately hiring for Quality Assurance Specialist in Cedar Creek, Texas

As a Quality Assurance Specialist, you will:

• 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.

This is a full-time- contract opportunity.

The Ideal Candidate will have:

• Bachelor's or master's Degree in biology, chemistry, biotechnology, engineering, or a related field, or equivalent experience.
• Post-graduate, Quality Assurance Certifications, such as Six Sigma, CQA, etc., is preferred.
• 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.

PAY RANGE AND BENEFITS:

Pay Range*: $50 - $52.10 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: Volt offers benefits (based on eligibility) that include the following: health, dental, vision, term life, short term disability, AD&D, 401(k), Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

Volt is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Volt 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 email [e-mail] or call (866) -898-0005. Please indicate the specifics of the assistance needed.

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.