Pinnacle Technology · 6 hours ago
Principal Quality Engineer
Marlborough, MA
Contract
Onsite
Lead/Staff
$65/hr - $70/hr
8+ years expPinnacle Technology is seeking a Principal Quality Engineer to ensure that Quest Diagnostics’ IVD products meet stringent regulatory requirements and quality standards. This role involves leading quality engineering initiatives, supporting product development and manufacturing processes, and driving continuous improvement in the quality management system.
ConsultingInformation TechnologyOutsourcingSoftware
Hiring Manager
Aditya Verma
Responsibilities
Develop, implement and maintain quality systems and processes in compliance with FDA CFR Part 820, ISO 13485, IVDR 2017/746, ISO 14971 and other regulations, as appropriate, for IVD products
Conduct hazard analysis and risk assessments for IVD products according to ISO14971 throughout the IVD product lifecycle
Qualification
Required
8+ years of experience in Medical Devices and/In Vitro Diagnostics (IVD)
8+ design and development with a strong focus on design control and risk
8+ management
Bachelor's Degree (Required)
Preferred
Experience in working effectively in an FDA-regulated environment
Experience working with IVD products
Analytical mindset with attention to detail and a commitment to integrity, product safety, and Quality
Demonstrated Experience applying medical device regulations (e.g. IEC 62304, FDA 21 CFR Part 803, 21 CFR Part 806, 21 CFR Part 820, ISO 13485, ISO 14971, IVDR, CAP, and CLIA)
ASQ Certification preferred
Regulatory Affairs Certification (RAC)
Company
Pinnacle Technology
Pinnacle Technology provides staffing solutions, outsourcing, and systems integration services.
201-500 employees
Funding
Current Stage
Growth StageRecent News
GlobeNewswire News Room
2025-02-21
Company data provided by crunchbase