Job Description:

One World Technologies, Inc dba TTI Power Equipment, has an opening in its Anderson, SC office for a Quality Systems Engineer. We offer competitive wages and a comprehensive benefits package -- tuition assistance, 401(k), medical/dental/vision coverage, vacation and holidays.

Job Summary:

The Quality Systems Engineer will oversee and manage the quality systems and ensure compliance with regulatory standards and internal policies. This role will be responsible for developing, implementing, and maintaining the MasterControl system, ensuring all quality processes and documentation are accurate, up-to-date, and effectively managed. The successful candidate will lead quality improvement initiatives, conduct internal audits, and provide training to ensure continuous quality enhancement across the organization.

Key Responsibilities:

MasterControl Management:

Develop and maintain the MasterControl system, including document control, change control, and training management.Ensure all quality documents are properly reviewed, approved, and controlled.Manage the document lifecycle, including creation, revision, approval, distribution, and archival.Coordinate with different departments to ensure timely updates and availability of quality documents.Oversee the implementation of change controls, ensuring that changes are assessed, approved, and implemented according to established procedures.

Quality Systems Oversight:

Develop, implement, and maintain quality management systems (QMS) in compliance with ISO9001 and regulatory requirements.Conduct internal audits to ensure compliance with QMS and identify areas for improvement.Lead quality system improvement projects, driving continuous improvement and ensuring best practices.Ensure proper training of staff on quality systems and processes.

Compliance and Auditing:

Prepare for and participate in external audits and inspections by regulatory bodies and customers.Ensure that all quality records are maintained and retrievable for audits.Conduct root cause analysis and implement corrective and preventive actions (CAPAs) for any identified quality issues.

Data Analysis and Reporting:

Analyze quality data and trends to identify opportunities for improvement.Prepare and present quality reports to senior management, highlighting key metrics and improvement initiatives.

Training and Support:

Develop and deliver training programs on quality systems, MasterControl, and regulatory requirements.Provide ongoing support and guidance to staff regarding quality systems and compliance matters.

Qualifications:

Education and Experience:

Bachelor’s degree in Quality Management, Engineering, Life Sciences, or a related field is preferred.Minimum of 5 years of experience in quality assurance or quality systems management, preferably in a regulated industry (e.g. manufacturing, pharmaceuticals, medical devices).

Skills and Competencies:

Strong knowledge of Quality Management Systems (e.g., ISO 9001, ISO 13485).Proficient in MasterControl and document management.Knowledgeable in Planview ProjectPlace is preferred.Excellent organizational and project management skills.Strong analytical and problem-solving abilities.Effective communication and interpersonal skills.

Certifications:

Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or similar certification is preferred.

Working Conditions:

Office environment with occasional visits to production or laboratory areas.Some travel may be required for audits, training, or conferences.

Benefits:

Competitive salary and benefits package.Health, dental, and vision insurance.401(k) with company match.Professional development opportunities.