Quality Engineering, Advanced / Quality Assurance Specialist

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

Benefits offered by this job

Health

Dental

Vision

Term life

Short term disability

AD&D

401(k)

Sick time

Paid leaves

Employee Assistance Program (EAP)

Job summary

Volt is hiring a Quality Assurance Specialist in Cedar Creek, Texas. You will drive QA tasks including batch review, NCRs, deviations, CAPAs, and audits, while ensuring compliance with ISO 13485, FDA 21 CFR 820, and IVDR.

This is a full-time contract opportunity requiring 4+ years in life sciences and relevant certifications. The role emphasizes problem solving, project leadership, and collaboration with cross-functional teams to improve processes and patient safety.

Qualifications

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

Responsibilities

• Drive QA activities related to batch review, change control, NCRs, deviations, CAPAs and audits.
• Support third-party audits and audit prep for the site.
• Apply QA methods and GMP principles to daily tasks.
• Lead root cause investigations and drive quality initiatives across the organization.
• Represent the organization in internal/external interactions on quality matters.

Skills

Analytical skills

Organizational skills

Quality Assurance

Education

Bachelor's or Master's in biology/chemistry/biotechnology/engineering

Tools

Regulatory knowledge (ISO 13485, FDA 21 CFR 820, IVDR)

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:

• 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 [phone]. 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.