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Category: Medical Device SubCategory: Quality Assurance JobNumber: DSM1001 Title: QA Compliance Director Region: New England Description: The QA Compliance Director oversees all quality compliance activities. The position has interaction with all other internal departments. The position has and/or supervises interaction with external entities including contractors and suppliers. The QA Compliance Director ensures, guides the performance of a wide variety of complex activities to ensure compliance with applicable regulatory requirements by overseeing quality compliance activities, performing quality activities, as needed, trending, and reporting quality trending activities and assessments, performing quality activities, as needed. Key Responsibilities Ensures that all QA Compliance systems conform with quality requirements. Manage and develop QA staff. Prepare and maintain budget, using appropriate resourcing. Ensure that projects are appropriately supported by Quality Assurance, and develop creative strategies and resourcing with regard to meeting project timelines. Benchmark data to identify opportunity for continuous quality improvement and guide strategy to implement. Set strategy for implementation of novel technology practices in Quality Assurance practices. Set strategy to meet corporate and departmental objectives and track performance against objectives. Perform as Project Leader to further corporate objectives. Qualification: Requires a Bachelor’s Degree or equivalent, with 12+ years of experience in a GMP/GLP regulated environment, and a demonstrated knowledge of scientific principles in a GMP/GLP environment. Requires 5-8 years management experience in a GMP/GLP regulated environment. ASQ CQA, CQE, or CQM/OE certification preferred. Contact: stephaniem@nsasearch.com Category: Medical Device SubCategory: Clinical Affairs JobNumber: DSM1002 Title: Clin Training Spec/Sr CTS Region: California (North and South) Description: The Clinical Training Specialist will provide primary on site education, training and support to assigned accounts providing technical information and education regarding the effective use of the client's system and related products. The CTS will also provide support to other accounts as necessary. The CTS will act as the primary clinical liaison to customers and the Company's sales organization. The CTS will assist sales personnel with pre and post sales activities. The CTS will assist customers with site specific administrative needs for the clinical implementation of the Therapy system. Territory to be covered includes the mainland United States with a major focus on the west coast accounts. Travel is mandatory. The CTS will identify and help resolve customer issues, and communicate problems to appropriate sources within the Company. The CTS will also assist in the development of new training and educational materials. Travel will be 75% of the time requiring overnight travel for up to 4-5 days at a time and sometimes weekends. The position is home office based. Clinical Training Specialist Qualifications Minimum BS in Health Sciences required Minimum Two years clinical teaching/in servicing/training experience. CNS/Psychiatry experience preferred Device experience training on capital equipment preferred Travel experience required Sr Clinical Training Specialist Qualifications BS in Nursing or other advanced degree in Health Sciences required Minimum Five years clinical teaching/in servicing/training experience. CNS/Psychiatry experience preferred Device experience training on capital equipment preferred Travel experience required Qualification: Clinical Training Specialist Qualifications Minimum BS in Health Sciences required Minimum Two years clinical teaching/in servicing/training experience. CNS/Psychiatry experience preferred Device experience training on capital equipment preferred Travel experience required Sr Clinical Training Specialist Qualifications BS in Nursing or other advanced degree in Health Sciences required Minimum Five years clinical teaching/in servicing/training experience. CNS/Psychiatry experience preferred Device experience training on capital equipment preferred Travel experience required Contact: stephaniem@nsasearch.com Category: Medical Device SubCategory: Manufacturing JobNumber: mfg100 Title: TestEngneer Region: SF Bay Area Description: Fll Time Test Engineer Qualification: 5 years Contact: Bob Rossi Category: Medical Device SubCategory: JobNumber: Title: Region: Description: Qualification: Contact: Category: Medical Device SubCategory: Clinical Affairs JobNumber: Title: Region: Description: Qualification: Contact:
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