Quality Engineer

Quality Engineer San Antonio, Texas Long Term Contract Job Summary: We are seeking a detail-oriented and highly skilled Quality Engineer to join our team in the Pharmaceutical / Medical Device industry.

The ideal candidate will ensure that all products meet internal and external requirements, including regulatory compliance, safety, and customer expectations.

You will play a key role in quality assurance, continuous improvement, and regulatory adherence (FDA, ISO 13485, GMP). Key Responsibilities: Develop, implement, and maintain Quality Management Systems (QMS) per GMP, ISO 13485, and FDA regulations.

Lead investigations of non-conformances, CAPA (Corrective and Preventive Actions), and root cause analysis.

Perform risk assessments (FMEA, HACCP) and implement mitigation strategies.

Review and approve change controls, deviations, validation protocols, and engineering documentation.

Participate in internal and external audits (e.g., FDA, ISO, customer). Monitor production processes and perform inspections to ensure product quality and compliance.

Support product development by reviewing specifications, procedures, and test methods for quality compliance.

Work cross-functionally with Manufacturing, R&D, Regulatory, and Supply Chain teams.

Generate and analyze quality metrics and reports for continuous improvement initiatives.

Train employees on quality procedures, regulatory compliance, and best practices.

Qualifications: Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related field.

2–5 years of experience in Quality Engineering within Pharma or Medical Device industries.

Strong knowledge of FDA regulations, ISO 13485, 21 CFR Part 820, and GMP standards.

Proficient in quality tools such as CAPA, FMEA, Root Cause Analysis, SPC, and DOE.

Experience with quality systems (e.g., TrackWise, MasterControl, Veeva QMS) is a plus.

Excellent analytical, problem-solving, and communication skills.

ASQ CQE certification or similar is preferred.

Preferred Soft Skills: Attention to detail and precision.

Ability to multitask in a regulated, fast-paced environment.

Strong interpersonal skills and ability to work both independently and within a team.

Proactive approach to quality and compliance.