QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
- Quality Lead is responsible for overseeing all aspects of product quality within the injection molding operations.
- Develop, implement, and maintain quality systems (ISO 9001, or customer-specific standards).
Establish and monitor quality control plans, inspection procedures, and testing protocols. - Lead root cause analysis and corrective/preventive actions (CAPA) for nonconformities.
- Ensures compliance with customer specifications, industry standards, and regulatory requirements while driving continuous improvement initiatives.
- Establish and inspect quality control processes and audits.
- Perform inspection of parts and interpret engineering drawings/blueprints.
- Ensure inspections and documentation comply with GMP and quality standards.
- Support quality activities during the assigned shift and provide guidance as needed.
Qualifications:
- Bachelor's degree in quality management, or a related field. (Preferred but no required)
- 3 to 5 years of experience in quality assurance within injection molding or plastics manufacturing.
- Strong knowledge of ISO standards, Validations, PPAP, FMEA, SPC, and GD&T.
- Experience with metrology equipment and statistical analysis tools
- Proficient in the use of measurement tools and verification of their calibration.
- Strong documentation skills.
- Leadership abilities.
- Quality-driven and detail-oriented mindset.
- Proven knowledge in the use of micrometers, calipers, optical comparators, and basic measuring equipment.
- Bilingual (English/Spanish) preferred.
- 1st shift but candidate must be available to work 2nd or 3rd shift if needed.
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
