Sr Engineer

Thousand Oaks, California | Contract

Post Date: 02/17/2017 Job ID: 2462 Industry: Engineering

The Senior Quality Engineer will employ quality principles and company’ s procedures to ensure development and sustaining of these mechanical and electro-mechanical medical devices complies with applicable regulations and standards. The qualified candidate will work within cross-functional project teams to develop and maintain detailed engineering specifications, support device design & development, verification, validation, and regulatory submissions of these devices. The role of the Senior Engineer is to work within a cross-functional organization to provide technical expertise and represent Quality functions and needs.

Key Responsibilities:
• 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.
• Review and approve requirements, specifications, development plans, verification and validation plans, protocols, reports and other related product development documents for assigned projects.
• Ensure project activities conform to appropriate SOPs, standards and regulations.



Basic Qualifications:

Master' s Degree & 3 years of Quality, Engineering or Operations experience

OR

Bachelor’ s degree and 5 years of Quality, Engineering or Operations experience


Preferred Qualifications

BS in Engineering and previous experience in medical device industry

5+ years of Quality, Engineering or Operations experience in the pharmaceutical or medical device industry with progressively increasing responsibility and demonstrated experience

Experience with quality systems including: 21 CFR 820, Part 4 Combination Products, Medical Device Directives (MDD), ISO 13485 and ISO 14971

Knowledge of Design Controls

Experience with product design enhancements/improvements

Experience in interacting with regulatory agencies

Good written and verbal communication skills

Ability to interpret and apply regulatory and quality requirements

Ability to work independently as well as on teams

Ability to prioritize and manage multiple tasks

Ability to work in a challenging and fast-paced work environment


 

The qualified candidate will lead technical teams to ensure successful device development of these disposable type mechanical and electro-mechanical medical devices. 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. 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.

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