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Knowledge of cGMP regulations, automation standards, FDA, EMA and PMDA guidelines applicable to biologics and cell therapy. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
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A Bachelor’s or Associate degree is a plusMinimum 3 years supervisory experience; 5 years of experience in a production environmentBasic PC skills including Microsoft Office, specifically Microsoft Excel and PowerPointExperience in material control, production control and quality control processesExperience working in the medical device industry (ISO, GMP, FDA, QSR, etc.
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Minimum of 5 - 8 years of relevant document control records management experience in a cGMP/FDA regulated environment. FDA Documentation & Compliance like 21 CFR Part 11/CGMP. Innova Solutions is immediately hiring for a QA Associate Specialist - Document Control.
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Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
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Working knowledge of all FDA submission requirements; including 510(k), Q-Submission, IDE/IRB Clinical submissions. Plan, develop, prepare, and obtain timely approval for product submissions to FDA and other worldwide regulators for Verathon's products.
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G: US FDA, EU MDR, TGA, MHLW, NMPA, etc. Develop and maintain an effective working relationship with US FDA and other international regulatory bodies/competent authorities. You have Relevant training, experience and/or certifications (ASQ Quality Manager, Auditor, Six Sigma, DFSS, reliability engineering), Continuous Improvement methodologies and Quality tools such as Lean, Six Sigma, 5 Why’s, Fishbone, etc.
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Minimum of 1 year of relevant document control management experience in a cGMP/FDA regulated environment. Experience interacting with FDA or other regulatory agencies strongly preferred. The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client Jump site, including the document change control process, issuance and reconciliation of batch records, batch related forms, product labels, and management of archival and retention of GMP records.
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Experience working in the medical device industry (ISO, GMP, FDA, QSR, etc). Lean Six Sigma Green Belt certification is a plus. Work with Engineering staff and Value Stream Manager to provide unique solutions to process issues.
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Jointly responsible for performing required quality control activities as mandated by the Mammography Quality Standards Act (MQSA) and the FDA. Dependent on location, may be required to utilize general radiography skills to perform diagnostic radiology exams.
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Seven or more years of product development experience, with at least five years designing electro-mechanical devices or a similar type FDA regulated medical device strongly preferred. The Senior Mechanical Engineer will be responsible for planning and executing technical projects consisting of the design, fabrication, modification, and evaluation of components involving both mechanical and electro-mechanical devices culminating in high performance, innovative transducers.
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Mammography Technologist - Pacific Medical Center Radiology Diagnostic for Pacific Medical Center (1.0 FTE, Day Shift) at Beacon Hill and Canyon Park, WA. Keywords: Mammography Technologist, Location: BOTHELL, WA - 98021.
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Experience working within a rigorous, quality control environment such as FDA cGMP/QSR or ISO is a plus. Experience working within a rigorous, quality control environment such as FDA cGMP/QSR or ISO is a plus.
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Experience working within a rigorous quality system environment (ISO, FDA cGMP/QSR, risk management, regulatory affairs, design control) The Sr. Director of Global Product Experience is responsible for leading Solta's Global product experience and technical service operations in accordance with both FDA QSR guidelines, Solta's quality policy, and defined commercial business objectives.
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Lamination tooling and stack assembly tooling to support current and new architectures. As the creator of point of care ultrasound, we dedicate every day to the innovation and development of imaging solutions that enable clinicians to provide improved healthcare in leading institutions, underserved populations and communities in crisis around the globe.
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Experience working within a rigorous, quality control environment such as FDA, cGMP/QSR or ISO required. Operation of a variety of mechanical and electro-mechanical assembly, curing fixtures and equipment.
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