Director of Software Quality
Partial Job Description
1) Establish and implement software quality assurance processes and procedures for product and non-product software using guidance from US and international guidance and standards
2) Develop and maintain software quality assurance procedures
3) Ensure product and non-product software quality assurance, including software development lifecycle and validation
4) Support new product submissions for products containing software
5) Review and/or perform software validations, including preparing protocols as well as reviewing and approving protocols from other authors
6) Assist in design, development and maintenance of a quality system compliant with cGMPs, ISO and other international regulations
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.
1) Follow our CEO on Twitter for status-updates about your job application:http://www.twitter.com/sterlinghoffman
2) Add our CEO on Facebook:
We will try to respond to your questions privately via Twitter or Facebook only.
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
Qualifications / Skills Required
1) BS or MS in a technical, scientific or engineering discipline
2) ASQ certification (CSQE, CQE, CRE, CQA) preferred
3) Minimum 8 years of experience in medical devices, in-vitro diagnostics, pharmaceuticals or a related industry
4) Experience working with the FDA and/or ISO auditors (preferred)
5) Experience in new product submissions for products containing software (preferred)
6) QA experience in software (preferred)
7) Excellent working knowledge and experience of FDA's quality system requirements (QSR), ISO 9001 and ISO13485:2003 standard
8) Ability to coordinate multiple projects
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.