Quality Assurance Specialist - Device History Record (DHR)

Philips•Latham, NY

1d•Onsite

About The Position

This individual ensures Device History Records meet regulatory and internal requirements and provide adequate verification of compliance to the product’s engineering specifications. The Quality Assurance Specialist is a member of the Operations Quality team in Latham which ensures compliance with legal, regulatory and international standards as they apply to Latham’s Quality Management System. This role is critical in ensuring that manufacturing records for components of medical devices are compliant with applicable standards and regulations prior to releasing product from the factory. The employee reviews electronic and paper records to ensure completeness, accuracy and compliance to defined specifications and requirements. Nonconformances are identified and corrected prior to allowing shipment of product from the facility. This position reports into the Quality Management System Manager. The employee will work directly with Operations, Quality Engineer and Quality Control teams to make sure information is accurately and completely recorded, and corrected, as needed. This employee will have the opportunity to work closely with other Quality, Manufacturing and Design Engineers on a site that has led innovation in the design of magnets for Magnetic Resonance Imaging (MRI) systems.

Requirements

1+ years of experience in medical device or a regulated industry, preferred
Proficiency in Good Documentation Practices (GDP)
General understanding of ISO 9001, ISO 13485, FDA CRF 21 part 820 and Good Manufacturing Practices (GMP)
Proficient with Microsoft Office applications
Technical Diploma, or Bachelor or Associates Degree in engineering science, or equivalent work experience
Ability to successfully perform the minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position
US work authorization is a precondition of employment
Must reside in or within commuting distance to Latham, NY

Nice To Haves

Experience with eQMS (Trackwise, EtQ) and ERP (SAP) software desired

Responsibilities

Ensure Device History Records meet regulatory and internal requirements and provide adequate verification of compliance to the product’s engineering specifications
Ensure compliance with legal, regulatory and international standards as they apply to Latham’s Quality Management System
Ensure that manufacturing records for components of medical devices are compliant with applicable standards and regulations prior to releasing product from the factory
Review electronic and paper records to ensure completeness, accuracy and compliance to defined specifications and requirements
Identify and correct nonconformances prior to allowing shipment of product from the facility
Work directly with Operations, Quality Engineer and Quality Control teams to make sure information is accurately and completely recorded, and corrected, as needed
Work closely with other Quality, Manufacturing and Design Engineers