Job Description :
Role: QA Tester with Validation Testing(FDA)
Location: Irvine CA
Duration: 6+ Months
Quality Engineer with experience in Medical industry to responsible to lead DHF gap assessment & remediation activities
Specific Search Key Words :
Key Words: Quality Engineering + Medical Device + FDA + design control + Validation + statistics
Primary
· Actively represent Quality Assurance function on product/process project teams.
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.
Lead or participate in design reviews to evaluate designs and to help identify alternative design solutions.
Develops master test plans that encompass design verification, design validation and process validation activities.
Test Method and Process Validation remediation including approaches and methodologies for validation
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.
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.
Analyzes and investigates returned clinical investigation products to determine the cause for return.
Contributes to design input requirements from experience with previously reported problems competitive devices and/or other similar products.
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 Medtronic 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
Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.
Secondary:
· Experience in vascular devices, embolic coils, stents, catheters, balloons, aspiration devices, coatings and/or guide wires.
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 Engineering responsibilities
Certified Quality Engineer (CQE) / Certified Biomedical Auditor (CBA) preferred

Client : Resource Logistics Inc.