Now hiring....Operations Quality Manager at our Global Pump Shared Services/U.S. Factory Service Center in San Jose, CA.Aspire...to work to save the lives of others, while shaping your own. Discover a new and exciting career in the world of serialized device pump technology driven to improve the safety and effectiveness of patient care for millions of people. If you're a highly motivated individual looking to make a difference and believe your professional goals are in alignment with Hospira; then you're ready to advance wellness at our operations in San Jose, CA.Under the direction of the Plant QA Manager, the U.S. Factory Pump Service Center in San Jose, California is searching for an Operations Quality Manager. The Operations Quality Manager will manage the Quality Engineering, Compliance and Complaint departments by providing direction and tactical oversight to team members. You will manage QE team support for site engineering on-market design changes and design for reliability utilizing risk management and reliability engineering tools.You will ensure compliance to corporate policy and design control requirements for on-market product design changes. In addition, you will manage the complaint approval process and the Test and Investigation lab.You'll manage the coordination, preparation and completion of internal and external audits in compliance with regulatory and company requirements as defined in the Quality System Regulations. You will manage a customer-focused technical organization actively supporting quality engineering efforts which includes establishing department responsibilites and goals, including writing and delivering performance reviews for the team.You will provide quality engineering leadership and support for manufacturing process development including PFMEA, process flow mapping, process control planning, process validation and monitoring, manage statistical data flow for Quality Management Review, CAPA effectiveness and field action protocol.In addition, you will deliver proven leadership and support for site compliance remediation programs and audit readiness initiatives, the interpretation and application of specified regulations and interfacing with regulatory agencies, including the FDA.This role supports design verification and validation for test method development, execution and reporting including test equipment qualification and test method validation for product release, managing statistical data for Quality Management Review, CAPA effectiveness and field action protocol along with leading monthly Quality Management Review meetings.
Bachelors degree required, preferably in a technical discipline (Engineering, Science, Statistics, etc..)Proven management/leadership skills with minimum 7-10 years experience in an FDA regulated work environment. Preferred Certification and/or license in specific discipline (i.e. CQE, CQA, CMQ, ISO 13485 Lead Auditor, etc.).Demonstrated knowledge of manufacturing and support of medical devices that meet the requirements of ISO 13485, 21 CFR Part 820 and other applicable regulatory standards. Thorough knowledge and understanding of quality and GMP/GLP practices, methods and techniques.Advanced communication skills with the ability to communicate at all levels of the organization both orally and in writing.Superior organizational skills with ability to multi-task and balance complex and routine work activities. Ability to prioritize and delegate.Demonstrated ability to lead people and get results through others. Proven teambuilding skills and ability to negotiate and influence others. Self-motivated and acts with a sense of urgency yet ensures quality and integrity of product and processes.MS Office and experience with other system software applications.Upon approval, will act as Site Quality Manager delegate.