ISO 13485 Jobs in USA
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Requirements Engineer Lead
Coopercompanies
DescriptionThe Research and Development Digital Innovation team within CooperSurgical leads efforts to translate user needs into product solutions and define and document product development requirements. The Requirements Engineer Lead is a leadership role that will be responsible for both leading p...
Quality Engineer
Gn Group
Position OverviewThis position is responsible for supporting Quality processes and systems compliant to FDA regulations and ISO requirements related to the sale manufacture service and distribution of Hearing Instruments and related accessories.Essential Functions (Reasonable accommodations may be m...
Quality Engineer
Resound
Position OverviewThis position is responsible for supporting Quality processes and systems compliant to FDA regulations and ISO requirements related to the sale manufacture service and distribution of Hearing Instruments and related accessories.Essential Functions (Reasonable accommodations may be m...
Quality Inspector
Gn Group
Position OverviewThis position works within the Quality Department in the local Minnesota office(s). They will collaborate frequently with Receiving Inventory Quality Engineering and Purchasing departments.The Quality Inspector will perform inspections on purchased materials as well as in-process pr...
Vice President, Medtech Cardiovascular Regulatory ...
Iqvia
MCRA is part of IQVIA MedTech. As a trusted CRO and advisory partner IQVIA MedTech and MCRA deliver integrated lifecycle solutions for the medical device and diagnostics industry. Together we support innovation from concept to commercialization offering expertise in regulatory strategy clinical tria...
Sr. Associate Ii, Regulatory Affairs Strategy
Alcon Research
At Alcon were passionate about enhancing sight and helping people see brilliantly. With more than 25000 associates worldwide we innovate fearlessly champion progress and act with speed to advance global eye health. At Alcon youll be recognized for your contributions supported by an inclusive culture...
Quality Inspector
Resound
Position OverviewThis position works within the Quality Department in the local Minnesota office(s). They will collaborate frequently with Receiving Inventory Quality Engineering and Purchasing departments.The Quality Inspector will perform inspections on purchased materials as well as in-process pr...
Senior Category Manager Plastics
Exact Sciences
Help us change livesAt Exact Sciences were helpingchange how the world prevents detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career an inclusive culture and robust...
Qa Materials Release Technician
Coopercompanies
DescriptionAt CooperVision a division of CooperCompanies were driven by a unifying purpose to help people to experience lifes beautiful moments. We are connected through our shared values - dedicated innovative friendly partners and do the right thing. As a leading global manufacturer of contact len...
Product Complaints Specialist Aid
Werfen
IntroductionWerfen Werfen is a growing family-owned innovative company founded in 1966 in Barcelona Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis Acute Care Diagnostics Transfusion Autoimmunity and Transplant. Through our Original Equipment Manufacturing (OEM...
Quality Inspector Ii
Cretex
OverviewAbout Cretex Medical Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding laser processing metal stamping and device assembly. Learn more at .Qual...
Oligo Manufacturing Technician 1
Lgc Group
Position SummaryThe GMP Oligo Manufacturing Technician I is responsible for supporting oligonucleotide manufacturing in an ISO 13485 regulated environment. This position performs production procedures in compliance with current Good Manufacturing Practices (cGMP) Standard Operating Procedures (SOPs)...
Sr. Systems Engineer
Abbvie
AbbVie is looking for a Sr. Systems Engineer to join their Combination Product Development team. This individual will contribute to the development and launch of exciting new drug / device combination products.As a Sr. Systems Engineer you will be responsible for the integration of multiple discipli...
Director, Regulatory Affairs Devices And Combinati...
Abbvie
The Director Regulatory Affairs Device is responsible for combining knowledge of scientific regulatory and business issues to support and drive strategy for regulatory submissions including new applications and amendments renewals annual reports supplements and variations. Has influence and responsi...
Director, Regulatory Affairs Devices And Combinati...
Abbvie
The Director Regulatory Affairs Device is responsible for combining knowledge of scientific regulatory and business issues to support and drive strategy for regulatory submissions including new applications and amendments renewals annual reports supplements and variations. Has influence and responsi...
Senior Project Manager – Advanced Energy Devices
Intuitive
Primary Function of Position:The Senior Project Manager Advanced Energy Devices on the Future Forward PMO team will be responsible for leading the end-to-end development of advanced energy medical devices including ablation and resection capital equipment. The Senior Project Manager drives innovati...
Senior Quality Systems Engineer
Access Vascular
Job Descriptions:Manage the Access Vascular Inc (AVI) Quality Management System for a growing start-up company that designs manufactures and distributes sterile catheter- software- electromechanical-based medical device product families. Provide Quality Engineering support for Operations and Operati...
General Assembler I
Coopercompanies
DescriptionAbout CooperSurgicalCooperSurgical is a leading fertility and womens healthcare company dedicated to putting time on the side of women babies and families at the healthcare moments that matter most in life. As a division of CooperCompanies were driven by a unified purpose to enable patien...
Manager, Qa Operations
Maravai Lifesciences
Who we are:Maravai LifeSciences translates extraordinary science into everyday miracles helping biotech biopharma and life sciences companies everywhere deliver novel vaccines therapeutics and diagnostics. We are global leaders in providing products and services within the fields of nucleic acid pro...
Regulatory Affair Specialist
Broadata Communications
Regulatory Affairs SpecialistBroadata Communications Inc. (BCI) Torrance CA On-site Company OverviewBroadata Communications Inc. (BCI) is a privately held California-based corporation. BCI is a leading and innovative company specializing in the development of market-driven products for the transmis...