Overview
Quality Control Specialist – Medical Device / Pharma Jobs in Westchester County, NY at Hoxton Circle
Title: Quality Control Specialist – Medical Device / Pharma
Company: Hoxton Circle
Location: Westchester County, NY
Our client, a leading developer, marketer, and distributor of medical equipment, is expanding their operations and seeking to add a dedicated Quality Control Specialist to their growing team.
The Quality Specialist is responsible for coordinating and executing a variety of quality assurance activities to ensure compliance with regulatory standards and internal requirements related to the mailing of sample collection devices directly to patients. This role plays a critical part in maintaining product quality and ensuring patient safety, privacy, and satisfaction.
Key Responsibilities:
Develop and draft specifications and documentation for direct-to-patient mailings and their components.
Manage document routing and approvals through the controlled document management system.
Review and approve labeling for patient mailings to ensure accuracy and compliance.
Conduct inspections of incoming materials and components in accordance with established quality procedures.
Determine and document material disposition (e.g., accept, reject) based on product specifications.
Perform material and product release activities, ensuring compliance with applicable quality standards.
Verify patient information and component availability before initiating shipment, maintaining HIPAA compliance at all times.
Perform in-process inspections of patient mailings to confirm adherence to specifications.
Identify, reject, and document nonconforming materials according to internal protocols.
Participate in continuous improvement initiatives and process validation efforts.
Support other QA/QC functions as needed.
Consistently apply knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
Maintain a clean and organized work area; ensure proper use and care of office and quality-related equipment.
Qualifications:
Bachelor’s degree required (Science or Engineering preferred); 4–6 years of related experience in quality control or assurance.
Prior experience in GMP-regulated environments such as medical device, pharmaceutical, or biotech industries strongly preferred.
Solid understanding of quality management systems and regulatory requirements.
Detail-oriented with strong organizational and time-management skills.
Excellent written and verbal communication skills.
Proficient in Microsoft Office Suite and document management systems.
Ability to interpret and follow written procedures accurately.
Comfortable working in a cross-functional team and independently.
