Quality Systems Specialist

Quality Systems Sr Specialist

Location: Remote – Columbia

Duration: 12 Months

Job Type: Contract

Job Summary

We are seeking an experienced Quality Systems Sr Specialist to support the development, implementation, maintenance, and continuous improvement of the Quality Management System (QMS). This role will work closely with site and corporate leadership to strengthen quality processes, ensure regulatory compliance, improve documentation practices, and support quality system integration across multiple sites.

Key Responsibilities

• Develop, implement, and improve quality management processes, procedures, and work instructions.
• Support senior management in establishing and implementing quality system strategies and objectives.
• Coordinate the communication, distribution, and release of corporate quality documents across multiple sites.
• Develop and maintain site-level document control procedures and work instructions.
• Identify and implement process improvements to enhance site quality operations.
• Coordinate projects involving site integration and migration to standardized quality systems.
• Lead and support internal and external audits and assessments to ensure regulatory compliance.
• Support quality investigations, corrective and preventive actions (CAPA), and issue resolution activities.
• Coordinate and facilitate external quality standard assessments.
• Ensure quality processes align with applicable FDA, GMP, ISO, and global regulatory requirements.

Required Qualifications & Skills

• Strong working knowledge of U.S. FDA regulations, global regulatory requirements, and quality standards, particularly EU MDR.
• Experience with Quality Management Systems (QMS), including CAPA, management responsibility, product realization, measurement, analysis, and improvement processes.
• Knowledge of root cause analysis, problem-solving, and decision-making methodologies.
• Experience supporting internal and external audits, quality assessments, and compliance activities.
• Strong technical writing skills, including quality procedures, controlled documents, and work instructions.
• Familiarity with statistical data analysis tools and concepts.
• Proficiency in Microsoft Office Suite, Adobe Acrobat, Power BI, and various data sources.
• Excellent organizational skills, attention to detail, and interpersonal communication abilities.
• Ability to manage challenging situations and handle sensitive or controversial issues professionally.
• Strong commitment to regulatory compliance and quality standards.

Education & Experience

Candidates must meet one of the following minimum education and experience combinations:

• Bachelor's Degree with at least 4 years of relevant experience.
• Associate's Degree with at least 6 years of relevant experience.
• High School Diploma or equivalent with at least 8 years of relevant experience.

Preferred Qualifications:

• Bachelor's Degree in Life Sciences.
• Minimum of 5 years of relevant professional experience.