experience working as a Quality Engineer, preferably working in a medical device company. Specific experience... in our field. Spectra Medical Devices is one of the world's leading manufacturers of made-to-spec procedural needles...
Job Description: Applied Medical is a new generation medical device company with a proven business model... Up to five years of experience in the medical device or manufacturing industry, such as through internships or co-ops...
: Internal Audit Team: Lead the Bracco Medical Device internal audit program and serve as a Lead Auditor for internal audits... Minimum: Bachelor’s degree required. 5+ years medical device experience including at least 3 years in Quality Management Systems...
impact, Working knowledge of regulatory compliance requirements (i.e. Quality System Regulations (QSRs), Medical Device...), Quality Manager (CQM), and/or Supplier Quality Professional (CSQP) Quality Auditor qualifications or Lead Auditor...
Position: Quality Engineer II (Medical Device File Compliance Coordinator), Req#: CRNGJP00027779 Location: Kennebunk... is responsible for the development, maintenance, and management of Medical Device Files (MDFs) in accordance with ISO 13485 standards...
the Approved Supplier List. Act as lead auditor for supplier quality audits according to the established supplier audit... Quality engineering Medical device industry experience Auditing experience Quality assurance 4+ years of experience...
compliance to medical device standards as applicable. Review test methods for quality of verification and validation of the... and knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Regulation. * 5+ years' experience in IVD...
requirements throughout the post-market phase of our medical devices and solutions. This role will lead cross-functional teams...+ years in a regulated industry, particularly within the medical device, bio-pharmaceutical, or biotechnology sectors...
autonomously This position is responsible for the development, maintenance, and management of Medical Device Files (MDFs... Management System. Description of work: Developing, reviewing, maintaining, and updating medical device files in accordance...
in Quality Management Systems (e.g. ISO 13485, 9001, lead auditor, ASQ, etc.) Six Sigma Green Belt/Black Belt certification... or equivalent experience in quality engineering role in a medical device or life sciences technology driven company Experience...
in medical device/pharma industry. Experience to include ISO 13485, 21 CFR 820, MDD 93/42/EEC, EU MDR 2017/745, and MDSAP..., Excel, Access, Teams, Smartsheets, etc.) Lead Auditor Certified As an employee of CooperSurgical, you'll receive...
(e.g. ISO, FDA medical device regs, GCP, etc.). Collaborate with clinical sourcing, supplier quality and clinical... of work experience in the medical device/pharmaceutical/similar regulated industry Auditing experience in medical device...
(e.g. ISO, FDA medical device regs, GCP, etc.). Collaborate with clinical sourcing, supplier quality and clinical... of work experience in the medical device/pharmaceutical/similar regulated industry Auditing experience in medical device...
’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160..., or similar. Requires six to ten years increasing responsibility and experience in a medical device quality assurance environment...
support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing... products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device...
Certifications for Certified Quality Engineer (CQE), Certified Medical Device Auditor (CMDA), Six sigma black belt, or Certified... to medical device safety or efficacy. Address and remediate events that may contribute negatively to QMS processes...
in medical device manufacturing. Experience in medical device process and product validation, sampling, and statistics (e.g. DOE... techniques highly preferred. Prior experience as an auditor for both suppliers and internal audits highly preferred. Lead...
years of engineering experience; preferably in the medical device industry. CQE/CQA certification helpful..., specifications, drawings, quality systems and analysis trends. Participate in and lead continual improvement projects. Support...
Overview: About QTS QTS offers critical end-of-line services for medical device OEMs including finished device... supplier audit process, including acting as lead auditor for supplier and internal audits to assess compliance with regulatory...
Overview: About QTS QTS offers critical end-of-line services for medical device OEMs including finished device... systems. Experience with ISO 13485:2016 and FDA. Lead Auditor Certification. Ability to consistently achieve short and long...