If you're someone who is game for a challenge and has the RA and QA management experience our client is looking for, this could be the best opportunity out there for you! Read on...
1) Ensure quality products and processes by establishing and enforcing quality standards in compliance with ISO 13485:2003, ISO 14971:2007 and other applicable ISO standards, FDA QSR regulations and other FDA guidance, and requirements
2) Establish quality standards by studying product and consumer requirements with other members of management and with production manager, technicians and engineers
3) Maintain compliance with regulatory standards by studying FDA and other regulatory requirements
4) Implement requirements in processes, conducting audits and reporting results to management
5) Act as 'Official Correspondent' in FDA matters ensuring registration, listing medical device reporting, submissions and other FDA requirements
6) Maintain product quality by enforcing quality assurance policies and procedures, government requirements
7) Collaborate with other members of management to develop new product and engineering designs and manufacturing and training methods
8) Complete quality assurance and regulatory operational requirements by assigning tasks, conducting department audits, reporting audit results by following up on work results
9) Maintain quality assurance staff by recruiting, selecting, orienting and training employees
10) Maintain quality assurance staff job results by coaching, counseling and disciplining employees and planning, monitoring, and appraising job results
11) Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks and participating in professional societies
12) Achieve financial objectives by preparing the quality assurance budget, schedule expenditures and analyze variances and initiate corrective actions
13) Contribute to team effort by accomplishing related results as needed
14) Act as a customer specialist by ensuring customer requirements are met related to manufacturing, packaging and regulatory compliance
More questions? Want to know the Salary range? Keep reading.
The best way to get more details is to click ‘Apply’, upload your resume, and ENTER YOUR QUESTIONS in the ‘Cover Letter’ field. A recruiter will call you and answer all of your questions (if they feel you are a fit for the role). Your resume will be kept CONFIDENTIAL – we respect your privacy. Our Recruiters are more likely to respond to your questions if they know you are *seriously* interested, and prefer to know a little bit about your background before calling.
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TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Healthcare, Life Sciences, Scientist, R&D, Clinical Research, Clinical Trial, Regulatory Affairs, Nutraceutical, Surgeon, MD, Hospital, Immunology, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility, Hospital, Research and Development, Medical Affairs, Drug Safety
1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the medical device industry is strongly preferred
4) Preference will be given to people who have recent experience in RA and QA management
Our client provides their employees with support in an environment that promotes growth and success. If you share the same passion, they welcome your application for consideration!
Sterling-Hoffman Life Sciences is the premier recruitment firm in North America for companies involved in the research, clinical development, manufacturing and distribution of drugs and devices that allow patients to live healthier and more fulfilling lives. Leveraging a network of relationships in every major city – including New York, San Francisco, Raleigh-Durham, Chicago, Dallas, Denver and Los Angeles – Sterling-Hoffman Life Sciences is ideally positioned to assist fast growing CROs, pharmaceutical companies, biotech firms and medical device players in their quest to recruit the best people.