Job Description Responsibilities:
- Provide guidance and Quality oversight to ensure establishment and execution of sustaining programs aligned with regulatory requirements and industry standards.
- Support existing product sustaining activities to ensure work follows proper design
- control. Ensure controls meet Client and FDA regulatory requirements by actively identifying Quality needs, product improvements and customer requirements.
- Ensures adequate quality documentation and records are maintained to support life cycle of design history.
- Provide support for each aspect of design control and ensure tasks are completed adequately to include project planning, design inputs, critical to quality characteristics, risk analysis, design reviews, validations, verifications, and update
- design history files and other activities as needed.
- Perform customer complaint investigation and assess work performed by R&D and other Client business units to help ensure Quality issues with device(s) or component(s) are adequately addressed and when needed corrective actions are taken to prevent recurring quality issues.
- Work with Validation team providing Quality Engineering support for Product and/or Device transfer, Scale-Up, and Process Validation.
- Lead or participate in Risk Management activities appropriate to the initiative or situation.
- Monitor quality data from complaints process, Manufacturing reports, Service reports and customer input. Identifies, investigates, troubleshoots and resolves identified quality issues independently or by working with Manufacturing, Service, Engineering, Regulatory and Biostatics.
- Initiate Corrective and Preventative Action plans and perform effectiveness follow up.
- Support Regulatory Affairs, as appropriate, by providing input for submissions or response to agency queries. Support regulatory inspections as needed.
- Lead situation analysis and support activities relating to Field Corrective Actions, when needed.
- Work collaboratively and cross functionally to improve product performance. Utilize trouble shooting and problem-solving skills to identify and eliminate issues that negatively impact product performance
- BS Degree in scientific discipline: Engineering, Chemistry, Biochemistry or related science. Certified Quality Engineering (CQE) preferred.
- A minimum of 2 years of experience working within a quality function and supporting sustaining/manufacturing operations or able to applies knowledge and skills to a variety of standard activities. Works with moderate guidance in own area of knowledge.
- A minimum of 2 years of experience working in a FDA or ISO regulated environment or able to applies knowledge and skills to a variety of standard activities. Works with moderate guidance in own area of knowledge.
- Robust understanding of QSR, Design Control, ISO, Product Risk Management and GMPs as defined in CFR 820 and of industry standards but not limited to Green belt and Design for Six Sigma methodology and tools.
- Excellent people interaction, team building, and communication skills.
- Problem solving skills with experience in project management to include organization, prioritization, problem solving, and sound judgment are critical.
- Understanding of statistical analysis expected.
: 21-01755 : San Jose, CA: