Sr. Development Quality Engineer

Position Title : Sr. Development Quality Engineer

Location : Pleasanton CA 94588

Assignment Duration : 6 months

Schedule : 8 AM to 5 PM

Work Arrangement : Onsite

Position Summary : The Sr. Development Quality Engineer will serve as a technical representative providing design quality expertise to a product development team. Responsible for maintaining a strong collaborative partnership with cross-functional team members to achieve patient / user safety, customer satisfaction, and organizational success.

Key Responsibilities :

• Lead and / or support on-time completion of Design Control deliverables
• Support the establishment of objective, measurable, and verifiable product requirements
• Support Design Verification and Validation planning & execution, including any cross-functional investigation & resolution activities
• Lead Risk Management activities from product concept through commercialization
• Support test method development and lead test method validation activities
• Support manufacturing process development & qualification for new product and design changes
• Support the establishment of component specification definitions, supplied component sampling plan development, and vendor qualifications
• Support biocompatibility and sterilization qualifications
• Support audits and quality system improvement activities
• Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.
• Comply with U.S. FDA, EUMDR and other requirements, as applicable.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.

Qualification & Experience :