Quality Assurance Engineer, Robert Half

Quality Assurance Engineer

Robert Half

Location:

United States, Batesville, IN

Category:

Quality Control

Contract Type:

Not provided

Salary:

Not provided

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Job Description:

We are seeking a detail-oriented and proactive Quality Assurance Engineer to join our team. This role involves providing technical support for a variety of quality system processes and ensuring superior product quality across the product lifecycle. The successful candidate will play a pivotal role in driving continuous improvement efforts, analyzing quality data, and collaborating with cross-functional teams to identify and implement solutions.

Job Responsibility:

Implement and drive continuous improvement actions to enhance product quality
Collaborate with Engineering and Manufacturing departments to develop acceptance criteria for production processes
Investigate product issues by working with the Service and Complaint Handling Unit, conducting root cause analysis, and recommending corrective actions
Analyze production quality data to identify trends or issues that require corrective action or CAPA (Corrective and Preventive Action) initiatives
Assist in developing and implementing procedures into the quality management system
Conduct internal audits of production processes and prepare detailed results reports
Review manufacturing process deviations and part deviations, ensuring proper documentation and resolution
Support external regulator or customer audits, providing documentation and responses as needed
Respond to quality-related inquiries driven by tenders or sales efforts
Provide assistance for other quality assurance-related duties as requested

Requirements:

Bachelor of Science degree in Engineering or a related field
Minimum of 3 years of relevant work experience in a quality assurance role
Expertise in analyzing, evaluating, and controlling risk using lifecycle risk management standards (e.g., ISO 14971)
Experience with manufacturing/quality methodologies such as QFD, Six Sigma, Lean, or similar best practices
Familiarity with formal quality systems (e.g., ISO 13485 or ISO 9001)
Knowledge of statistical analysis techniques and experience utilizing relevant tools
Previous work in an FDA-regulated environment (preferred but not required)
Proficiency in understanding technical product documentation, such as diagrams, schematics, and flowcharts
Skilled in Microsoft Office tools (Word, Excel, PowerPoint, Outlook, etc.) and Windows-based systems

Nice to have:

Previous work in an FDA-regulated environment
Strong verbal and written communication skills in English
Ability to manage and prioritize multiple activities with attention to detail and strong organizational skills
Capable of both independent work and teamwork in dynamic environments
Adaptable, proactive, and flexible when faced with shifting priorities and tasks
Excellent record-keeping and documentation skills

What we offer:

Medical, vision, dental, and life and disability insurance
Eligibility to enroll in company 401(k) plan

Additional Information:

Job Posted:

March 24, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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