One Amgen Center Drive Thousand Oaks, California 91320 | Contract
Top 3 Must Have Skill Sets: 1. Engineering degree 2. Prior quality/engineering experience 3. Design controls experience
1. Bachelor’ s degree or higher in Engineering
2. Experience in medical device or pharmaceutical industry and FDA regulations
3. Experience being in an engineering position such as process, systems, quality, manufacturing, design, development, supplier quality, etc.
4. Experience with process control, non-conformances, CAPA, change control processes, validation, verification
5. Experience authoring or reviewing engineering documentation such as specifications, development plans, characterization plans, verification and validation plans, test protocols, reports
6. Design controls experience is preferred.
Day to Day Responsibility: As a Quality Engineer, lead and support project teams in the development and sustainment of drug delivery devices. Scope includes a wide range of devices such as needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, prefilled syringes and micro-infuser delivery pump systems. The Quality Engineer will work closely with team members in a cross functional environment to develop detailed user requirements and engineering specifications and support new and sustaining product development, verification, validation and regulatory submissions of these devices.
Description: The principal role of the Quality Engineer is to ensure compliance to design controls, SOPs and applicable standards and regulations while meeting the timeline of short-cycle robust device development. A good portion of the daily activities involve researching standards and guidance documents, authoring documents or review and approval of project deliverables.
• Work closely with suppliers, customers and other departments to meet quality needs.
• Identify deliverables and establish documentation required for project support in accordance with applicable SOPs, standards and design control principles.
• Author and/or review, execute and approve requirement documents, design documents, specifications, development plans, characterization plans, verification and validation plans test protocols, reports and other related product development documents for assigned projects.
• Ensure project activities conform to appropriate SOPs, standards and regulations.
• Work with Drug Delivery Engineering, Marketing, Regulatory, and Operations functions to define and access requirements and execute project plans for product development and successful integration of different sub systems.
• Evaluate the impact of any new product or changes to existing products on regulatory applications and conduct risk analysis
• Improve products through implementations of quality management specifications, procedures, test methods, measurement systems and best practices.
This position requires at a minimum a bachelor’ s degree, preferably in a technical field relating to engineering or science and previous experience with engineering processes and procedures in a medical device industry dealing with product development. This position will serve in a deadline and result driven environment and requires good negotiation and team interaction skills to assist in understanding and balancing requirements of different project groups. Strong analytical and problem-solving skills are required.