Assist Biometrics Department with developing tools and techniques for improving process efficiencies.
Performing quality assurance procedures on work performed by others.
Review statistical analysis plans and protocols.
Contribute to the development and documentation of analysis/clinical data set specifications, safety and efficacy analysis programming, as well as any ad-hoc programming requests.
Develop and maintain Programming standard and custom data listings, summary tables, and graphs as specified in statistical analysis plan.
Implement and follow the latest versions of CDISC, FDA guidelines, Good Clinical Practice, and other industry standards.
Provide input into case report form design, database structure design, and edit check development.
Minimum 3 years’ experience; preference for someone who has worked at multiple companies
Nursing or pharmacy background strongly preferred
Needs to have experience with the full case processing workflow (mailbox experience/assessing & triaging cases, data entry experience, quality check/review experience, follow up experience as well as submissions experience)
Argus database experience is an absolute must; experience with reports and listings in Argus, as well as experience coding AE and medication within Argus would be nice to have
Candidate would need to have a strong attention to detail, good communication skills, and ability to assess and think critically
6-8 years of Quality engineering experience.
Quality Engineering experience in Medical Devices (at least in Class I & II) at least 3 years.
Full Quality System Knowledge.
Extensive Gage R&R experience.
Process Control Plan
Measurement System Analysis Studies (Gauge R&R).
Process Capability Analysis (Cpk).
Process Qualification (e.g. IQ, OQ, PQ).
First Article Inspection (FAI).
First Production Inspection (FPI).
Critical to Quality (CTQ).
Mandatory Technical Skills:
Experience as a Verification and Validation Engineer for 5+ years
XRAY product testing experience [System Testing experience mandatory]
Strong knowledge of Microsoft Windows technologies
Strong belief in quality compliance and following rules
Strong working experience on setting up lab test equipment and setting up PC and Servers and deploying software onto target systems
Knowledge of testing medical products
Knowledge of FDA regulations required to test medical products
Expertised in quality reviews
January 12, 2018 – Regulatory Affairs Specialist – p b SRS Application Specialist (Submission Ready Standard Application): /b /p ul li Under the direction of the line manager the SRS specialist
January 12, 2018 – Associate Director, Global Regulatory Affairs (CMC) – p b Description: /b /p ul li The CMC Regulatory Affairs Network Strategy Implementation Team Lead will provide leadership and be the Regulatory
January 3, 2018 – Clinical SAS Programmer – p b JOB DESCRIPTION: /b /p p b Roles & Responsibilities: /b /p ul li Assist Biometrics Department with developing tools and techniques for