Sr. Quality Engineer
Title: Sr. Quality Engineer
Duration: Full Time
Location: San Jose CA
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The Sr. Quality Engineer is accountable for quality support for products developed and process design to achieve these goals through active participation and contribution to multi-functional and multi-divisional teams. The incumbent will be capable of self- direction and project management to ensure successful outcomes. The Sr. Quality Engineer is accountable for supporting new product development and/or product sustaining activities through the application of Quality engineering skills for medical devices. For Sustaining Product activities, this person will understand, improve, and control operational processes in order to realize predictable product flow while satisfying established Client standards of quality. Successful performance requires close work with quality management, operations, suppliers and/or Client associates to assure compliance with all Client quality policies, procedures, and practices.
Provide guidance and Quality oversight to ensure establishment and execution of sustaining programs aligned with regulatory requirements and industry standards.
Support new product design transfer activities and existing product sustaining activities to ensure work follows accurate design control. Ensure controls meet Client and FDA regulatory requirements by actively participating on product development teams and identifying Quality needs, product improvements and customer requirements.
Ensure adequate design control 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 design history files and other activities as needed.
Ensure the design is appropriately specified and established before transferring into manufacturing to avoid increased risk.
Review and authorize Quality approval for device design specifications including product performance specifications, test methods, acceptance criteria, and release.
Support product and/or device shipping studies by providing quality and regulatory requirements, approving protocols, assessing generated data and approving final reports.
Review 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 feedback. Identifies, investigates, solves problems and resolves identified quality issues independently or by working with Manufacturing, Service, Engineering, Regulatory and Biostatistics teams.
Initiate Corrective and Preventative Action plans and perform efficacy 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.
Education and Experience:
Bachelor's Degree in scientific field (Engineering, Chemistry, Biochemistry) or related science.
Certification in Quality Engineering (CQE) preferred.
Minimum of 5 years' of experience working within a quality function and supporting sustaining/manufacturing operations.
Minimum of 5 years' experience working in a FDA or ISO regulated environment.
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 good judgment are critical.
Understanding of statistical analysis expected.
Ampcus IncorporatedRockville, MD
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