Our client is a leading medical device company and is currently seeking an accomplished Director of Sterility Assurance to join the team. Here is an overview of the role:
1) Define and set quality standards for each R&D function and across multiple therapeutic areas and ensure that quality checks are performed across the business
2) Build quality control team and methodology, including collaboration with other functional managers and groups to deliver a comprehensive quality control effort
3) Identify risk, support in the development and track effective use of CAPAs across departments
4) Perform in-process checks and define and utilize metrics to monitor and report on compliance
5) Drive accountability and continuous improvement through training, SOPs and workflows as needed to proactively improve quality, efficiency, and standardization
6) Direct the implementation and maintenance of the company?s quality system, reporting on the performance of the quality system for review and improvements as required
7) Direct and track social compliance audits required by customers
8) Review, test and approve all licensed products prior to production or 3rd party testing
9) Enforce Standard Operating Procedures with the goal of maintaining quality and safety in accordance with the company?s standards, based on current regulations and up to date product development procedures
10) Perform comparison testing of competitive product for sales
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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 sterility assurance
This role is a great opportunity for the right person looking to advance their career with a great company.
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.