Quality Assurance Engineer — ISO/QSR & CAPA Focus

Vastek Inc; Kentucky; On-site; USD 34,000 - 49,000; Full time

Job summary

Vastek Inc. is seeking a Quality Assurance Engineer to ensure products, processes, and quality records meet quality standards and comply with the quality system.

The role involves implementing and maintaining the quality system, writing and communication responsibilities, and applying ISO/QSR knowledge to support regulatory compliance. You will execute QA deliverables, assist CAPA initiatives, and help develop QA procedures and training across the organization.

Qualifications

• Bachelor/Master level degree in Engineering, Technical Field, or equivalent.
• 1+ years technical experience.
• Previous Quality assurance/engineering experience preferred.

Responsibilities

• Implement and maintain the effectiveness of the quality system.
• Execute and provide on-time completion of QA engineering deliverables.
• Support Global CAPA team with training, CAPA oversight, and CAPA deliverables.
• Support decision-making and oversight of the quality systems, including CAPA systems.
• Develop and maintain QA procedures, forms, and systems; provide QA system training.
• Seek information and assist others on QA practices as directed.
• Participate in risk assessment related to QA systems.

Skills

Writing skills

Communication skills

QA Engineering

Education

Bachelor/Master degree in Engineering or technical field

Advanced degree preferred

Job description

We are hiring candidates for the Quality Assurance Engineer job role.

A Quality Assurance Engineer assures products, processes, and quality records conform to quality standards and establishes compliance with the quality system.

Job Responsibilities :

Responsible for implementing and maintaining the effectiveness of the quality system.

Demonstrated writing and communication skills are required for this position.

A thorough understanding of the ISO/QSRs and the ability to apply that knowledge with an understanding of business operations to achieve regulatory compliance are needed.

Execute and provide on-time completion of Quality Assurance (QA) engineering deliverables.

Maintains awareness of standards that regulate our industry. Support Global CAPA team with training, CAPA oversight, and CAPA deliverables.

Support decision-making and oversight of the quality systems, including CAPA (Corrective and Preventive Action) systems.

Support key stakeholders with developing and maintaining QA procedures, forms, and systems. Support QA system training.

Seeks out information with direction and is able to support other members of the organization on QA practices.

As appropriate, participates in the completion of risk assessment, as related to QA systems.

General Qualifications :

Bachelor/Masters level degree in Engineering, Technical Field, or equivalent (advanced degree preferred)

1+years technical experience

Previous Quality assurance/engineering experience preferred.

Thanks,

Job Types: Full-time, Contract

Salary: From $30.00 per hour

Schedule:

• 8 hour shift

Ability to commute/relocate:

• California, KY 41007: Reliably commute or planning to relocate before starting work (Required)