BD Puerto Rico LLC is seeking a Quality System Specialist for Product Release, responsible for ensuring compliance in product release processes within the medical technology field. The role necessitates attention to detail and collaboration across departments to maintain product quality and patient safety
Job Summary
This role is responsible for ensuring the timely and compliant release of manufactured products by reviewing documentation and verifying adherence to quality system requirements.
The position plays a critical part in maintaining product quality and patient safety within one of the world's largest global medical technology companies.
Candidates must be willing to work on-site at least 4 days per week to foster collaboration and innovation in the healthcare industry.
Matching Summary
Match Score: 85
BD Puerto Rico LLC is seeking a Quality System Specialist for Product Release, responsible for ensuring compliance in product release processes within the medical technology field. The role necessitates attention to detail and collaboration across departments to maintain product quality and patient safety.
Skills & Requirements
Must-have
Bachelor's degree in sciences
2 years regulated manufacturing experience
Knowledge of FDA 21 CFR Part 820 and ISO 13485
Review device history records and batch records
Verify quality control checks and testing results
Manage non-conformances and discrepancies
Nice-to-have
Experience with SAP ERP systems
Proficiency in Quality Management Systems
Strong analytical skills for documentation review
Ability to work independently in fast-paced environment
Effective cross-functional communication skills
Key Requirements
Bachelor's degree in sciences or equivalent
Minimum 2 years experience in regulated manufacturing
Demonstrated knowledge of Quality System Regulations