Regulatory Compliance (FDA, ISO 13485, 21 CFR Part 820). Requirements: 4-6 years in a regulated medical device or life... sciences manufacturing environment. Strong background in Supplier Quality Engineering. Hands-on production line experience...
). Expertise in development, validation, and management of the clinical study database throughout its life cycle, from CRF design...
in development, validation, and management of the clinical study database throughout its life cycle, from CRF design, database...
and ADaM. Proven experience with Unix and Windows operating systems. Understanding of the software development life cycle...
software development life cycle. Understanding of FDA guidelines. Good organization, time management and attention to detail...
Responsibilities: The Senior SAS Programmer / Statistical SAS Programmer is responsible for providing programming support for clinical trials and contributing to the development of departmental standards. This includes developing and val...
Job Description: The Senior Engineer, External Manufacturing and Supplier Quality provides strategic and tactical support to External Manufacturing by executing quality activities such as base business support and nonconformance root cause...
Job Description: The Senior Engineer, External Manufacturing and Supplier Quality provides strategic and tactical support to External Manufacturing by executing quality activities such as base business support and nonconformance root cause...
Responsibilities: Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, procedures and guidelines, the duties and responsibilities for this position are: Develop and implement qualific...
Job Description: We are seeking a motivated and innovative R&D Engineer to support the design, development, and testing of medical devices in compliance with FDA and ISO standards. The ideal candidate will work closely with cross-functiona...
Job Description: Experienced Component Engineer with strong expertise in equipment and process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Proven ability to man...
Roles & Responsibilities: A minimum of four (4) years of relevant work experience. Hands on production line experience with validations. NC/CAPA root cause analysis, FMEAs, NPI, Design Control, Supplier Quality, medical device. Someone...