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Job #02895

About our client Our client is a privately held biopharmaceutical company headquartered in CA that is dedicated to the research and diagnostics services. The company has strong financials, an experienced management team and a loyal customer base. They have developed an industry-wide reputation for a positive work environment and an aggressive training program that ensures employees are up to date on current trends and best practices. This is a strong opportunity for someone that wants to put their drive and initiative to work! Position Location Quality Systems Manager California Salary Highly competitive package, commensurate with experience Responsibilities 1) Ensure compliance, maintenance and continuous improvement of ISO 13485 certification 2) Act as the representative of the management for quality system 3) Lead internal audits/assessments of the quality management system as well as periodic monitoring, to ensure compliance to written procedures and regulatory requirements 4) Develop and ensure execution of quality strategy that meets the business’ needs based on feedback from customers, executives, the board, and regulatory bodies 5) Serve as an expert with key customers on quality issues (audits, GMP requirements, etc.) 6) Provide support to the Internal Team for the conduct and follow-up activities associated with site visits from clients as well as regulatory/accrediting agencies 7) Work with appropriate internal and external contacts to understand the FDA’s evolving IVD labeling requirements 8) Advise the executives and ensure compliance (where needed) 9) Work with departmental managers to develop key performance indicators 10) Manage the coordination and improvement of company-wide training programs Requirements 1) BS (or an advanced degree) in Biochemistry, Chemistry, Molecular Biology or Bioengineering or equivalent experience 2) Minimum 5 years of experience in the biomedical or biotechnology industry 3) Trained in quality management systems, ISO 9001, ISO 13485 and 21 CFR 820 4) Experience in validation and risk management 5) Knowledge of statistical techniques, including sampling plans, process control, DOE and reliability a plus 6) Technical knowledge of the development, manufacturing, QA and/or QC methods (related to molecular biology reagents) 7) Superb communication skills (oral and written) 8) Ability to work in a cross-functional team environment and interact effectively with all levels of the company