Quality / Validation Engineer - Advantage Technical

Quality / Validation Engineer

Position Type: Direct Hire

Position Location: Commerce, CA

Position Salary: $80,000 - $95,000 (Depending on Experience) + Bonus

Responsibilities:

• Responsible for the quality control of our product design and manufacturing process control.
• Understand the Quality System Regulations and ISO standards (13485 and 21 CFR) and facilitates improvements to the quality system while providing technical quality engineering support to research and development and manufacturing.
• Serve as a Quality member on new product development (R&D) and provides technical support or leadership of quality deliverables.
• Responsible to support R&D and Operations during all product development phases and develops process qualification activities, statistically sound sampling plans and process control plans including inspection/ test method development.
• Responsible for validation documentation of equipment, processes, methods, and software such as Master plans, IQ/OQ/PQ and Final Reports.
• Execute validation protocols and writes final reports.
• Coordinate necessary support personnel to ensure efficient and effective execution.
• Manage each phase of the validation as required across shifts to meet internal and external customer needs and ensure the exercise is performed and closed in a compliant manner.
• Use of statistical tools to facilitate design verification test sample size and test method validations.
• Lead Risk Analysis (FMEA-CA Design/ Process) meetings and generate final reports and actions requirements.
• Perform analyses of failed material in order to determine the root cause. Implement appropriate corrective actions.
• Work on new product transfers and actively participate in the qualifications and validations of product/ equipment and processes.
• Review and approve document changes (process and design) and sssist R&D in test method development and conduct test method validation.
• Participate on internal quality audits; Develop and implement quality systems in compliance with ISO certification.
• Review and approve receiving inspection requirements and sampling plans for components. Develop and improve QC inspection and testing method as needed.
• Backfill quality review, QC testing, receiving inspection and product release activities as required.
• Support the implementation of overall company validation strategy
• Perform role to ensure all validations are in compliance with company policies and procedures
• Assess, process and circulate protocols and final reports for review and approval
• Execute each phase of the validation and/or solicit support to ensure adherence to protocol requirements.
• Report and document Protocol exceptions; Liaise with scheduling/planning and sales as required to ensure communication and documentation flow throughout the process.
• Provide feedback to appropriate personnel on the validation activities and project status.
• Actively communicate and share knowledge as required with the process engineering group.

Responsibilities:

• Bachelor of Science, engineering, or similar related discipline
• 2+ years’ experience in a similar quality, validation or similar background (Healthcare or Pharmaceutical background is a plus)
• Experience and Knowledge in Good Manufacturing Practices (GMPs) and Quality Systems and ISO-13485.
• Strong background with a customer focus is highly preferred.
• Excellent communications skill both verbal and written are require
• Experience proposing innovative practices to ensure processes are efficiently validated and product could be available for sale to the appropriate market.
• Experience with medical instrumentation and disposables, in a regulatory environment (i.e. GMPs, ISO9001, ISO13485, etc.).
• Proficient in knowledge of variety of testing equipment (including Introns, pin gages, snap gages, micrometer, caliper, etc.).
• Proficient technical writing skills and use of documentation programs (e.g. Office Windows, Excel, Access, Power Point, etc.).
• Working knowledge of fundamental quality and statistical tools including SPC, DOE, Six Sigma.
• ASQ Certified Quality Engineer Preferred.

Benefits:

• Full Benefits: (Medical, Dental, Vision)
• 401K + Matching
• PTO
• Bonus