We are on the lookout for a driven individual with a passion for the medical device industry. One of our clients is looking to add a strong Validation Quality Engineer to their team:
1) Continually seeks to drive improvements in product and process quality
2) Conduct FMEA, raw material characterization, risk management and equipment method validations
3) Utilize standard statistical analysis and problem solving techniques to determine product acceptance, evaluate process capabilities and assist R&D in Design Control and process transfer to Manufacturing
4) Participate in design reviews for new product development and design/process changes
5) Prepare & review Validation protocols and final reports (IQ, OQ, PQ)
6) Prepare SOPs and inspection/test methods and other change control related documentation
7) Prepare Master Validation Plans and participate in process qualifications
8) Be responsible for ensuring all quality standards and specification are defined and achieved in line with appropriate regulatory requirements, especially the FDA Quality System Regulation and ISO 13485:2003
9) Fully participate in and successfully contribute to project teams typically including the following activities: product design and development, test of materials, preparation of specifications, process capability studies, research investigations, report preparation, and process/test documentation
10) Perform other tasks and duties as directed by the Director of Quality Assurance and Regulatory Affairs
11) Assist in maintaining company corporation quality system
More questions? Want to know the Salary range? Keep reading.
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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 have recent experience in quality engineering
If this seems like just the right opportunity to take your career to the next level, please apply - we want to hear from you!
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.