DC Quality Specialist

ABEC Inc•Wilson, NC

About The Position

The Quality Specialist will work under the direction of the DC QA Manager to ensure ABEC quality-assurance standards and procedures are met. Review standards, policies, and procedures, as well as carry out programs to evaluate the effectiveness of existing programs and write new standards and procedures as necessary.

Requirements

Bachelor's degree in Quality, Science, Engineering or other relevant technical discipline.
Qualified and experienced Lead Auditor, preferably within the medical device industry.
Proficient with Microsoft Office applications; including Word and Excel.
Excellent written and verbal communication skills.
Good organizational skills with the ability to multi-task.
Must work well both independently and in a team-oriented, collaborative environment.
Execute other tasks as assigned.

Nice To Haves

Infor Syteline ERP Software experience preferred.

Responsibilities

Maintain an active oversight of the quality systems to ensure it is fit for purpose and ensures compliance with procedures, requirements and best practice.
Organize and manage site preparation and manage audit back rooms for Regulatory and Corporate Audits.
Provide Quality Assurance support to all areas of quality department, ensuring compliance is maintained at all times.
Identify, lead and drive QA process improvement initiative as appropriate.
Prepare, implement and analyse key Quality Systems related documentation.
Maintain and support to the Corrective and Preventive Action (CAPA) program.
Maintain and support the Non-conformance program.
Delegate for the Manager, Quality Assurance, CMEU.
Prepare Management Review presentations as appropriate.
Provide meaningful Quality Assurance measurement while ensuring that in-house or external Quality issues are effectively prioritized and acted upon in a timely manner
Execute other tasks as assigned.
Ability to travel when required.