Job Title: Senior Quality Engineer- Test method Validation- Process Validation
Location: Irvine, CA
Duration: 12+ Months Contract
Educational Qualifications: Bachelor’s Degree in Engineering or Science (Life Sciences, Physics, ME, EE, IndustrialTechnology, etc.)
- This position requires expert knowledge on the remediation of Test Method Validation and Process Validation.
- Provide guidance to Engineering staff and other personnel and ensures that design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, and design review.
- Lead the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations.
- Develops master test plans that encompass design verification, design validation and process validation activities.
- Subject matter expertise in Test Method and Process Validation remediation including approaches and methodologies for validation
- Provides input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
- Promotes continuous improvement in design control activities and use of quality tools with design team.
- Participates in supplier selection process and specification reviews with suppliers to ensure that purchased items meet client specifications.
- Specifies quality characteristics and inspection plans for components, subassemblies, and finished devices.
- Evaluates and dispositions nonconforming materials and products used in pilot and clinical builds, to arrive at the most economical disposition, while meeting all quality system requirements.
- Comply with applicable FDA and international regulatory laws/standards and the Company's of Conduct.
- Represent client organisation as appropriate in FDA, notified body, internal, and otheraudits.
- Other duties as assigned or required.
- Expert knowledge on the remediation of Test Method Validation and Process Validation.
- Lead or participate in design reviews to evaluate designs and to help identify alternative design solutionst.
- Project Management skills to ensure project has required resources and meeting project timeline.
- Evaluates test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
- Analyzes and investigates returned clinical investigation products to determine the cause for return.
- Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.
- Self-motivated and committed to a team approach.
- Strong interpersonal, organizational and project management skills.
- Strong oral, presentation and technical writing skills.
- Demonstrated skills in decision making – preferably across a broad spectrum of Quality Engineeringresponsibilities.