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:
- Ensures that suppliers deliver quality parts, materials, and services.
- Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
- Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
- Responsible for projects associate to component acceptance activities and inspections process.
- Implement and work with inspection plans
- Review measurement qualification method.
- Negotiation with suppliers to implement correct acceptance activities and inspections process.
- Supplier qualification
Qualifications:
- Bachelor's degree in Engineering.
- 3+ years of experience in Supplier Quality, Quality Engineering, or Manufacturing Quality.
- Experience in regulated industries such as Medical Devices, Pharmaceutical, or Biotechnology.
- Knowledge of GMP, ISO 13485, FDA regulations, and quality management systems.
- Experience conducting supplier audits and supplier qualification activities.
- Familiarity with CAPA, Root Cause Analysis, FMEA, Control Plans, and Statistical Sampling techniques.
- Experience supporting New Product Development (NPD) and product transfer activities.
- Strong problem-solving, analytical, and communication skills.
- Ability to work effectively with cross-functional teams and external suppliers.
- ASQ CQE, CSQP, Lead Auditor, or Six Sigma certification preferred.
- Proficiency in English, both written and verbal.
- First shift
Skills Required
- Bachelor's degree in Engineering
- At least 3 years of experience in Supplier Quality, Quality Engineering, or Manufacturing Quality
- Experience in regulated industries such as medical devices, pharmaceuticals, or biotechnology
- Knowledge of GMP, ISO 13485, FDA regulations, and quality management systems
- Experience conducting supplier audits and supplier qualification activities
- Familiarity with CAPA, Root Cause Analysis, FMEA, Control Plans, and Statistical Sampling techniques
- Experience supporting New Product Development and product transfer activities
- Strong problem-solving, analytical, and communication skills
- Ability to work effectively with cross-functional teams and external suppliers
- ASQ CQE, CSQP, Lead Auditor, or Six Sigma certification
- Proficiency in written and verbal English
- Availability for first shift
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools. Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
