Description :
For more information on how to apply: Please email [link removed][email removed] or call Zahra at (408) 626-8300.
Quality Engineer Our Quality Engineering team is seeking a Quality Engineer. The person in this position will support Quality, Process, R&D and Manufacturing Engineering projects and assignments in a fast-paced medical device company. Technical expertise will revolve around the engineer’s knowledge of the FDA Quality System Regulation (QSR), Medical Device Directive (MDD), and applicable ISO requirements for medical device manufacturers, and the ability to work within established company directives therein. The Quality Engineer is responsible for ensuring compliance with applicable internal and external Quality System procedures and regulations. Responsibilities include, but are not limited to: leading product development teams in risk management and analysis, developing quality and reliability plans, performing and summarizing complaint analysis, developing inspection and measurement systems, and planning and implementing design verification and validation test strategies.
Duties and Responsibilities
• Represents Quality Assurance within the new product development teams to ensure compliance to QSR, MDD and company Quality System procedures while ensuring that devices meet established reliability goals. • Writes and executes product test protocols and summary reports. • Conducts product failure/complaint investigations, identifies root cause, and makes recommendations for corrective/preventive actions. • Develops product-specific quality plans, including inspection and testing methods, sampling plans and product acceptance criteria. • Develops process and inspection instructions, inspection and testing fixtures/gauges and performs the associated training. • Applies design control tools such as risk analysis, FMEA, product design optimization and design verification/validation. • Develops component and finished product quality plans, which ensure all design, reliability and quality requirements are met. • Performs statistical analyses for product testing, component and process qualification activities. • Supports manufacturing quality development activities such as statistical process control, measurement system analysis, process capability analysis and process optimization (DOEs). • Supports supplier quality systems auditing activities and participates in supplier selection, evaluation and development activities. • Develops and executes protocols and writes summary reports for product and process testing and/or characterization. • Develops, writes and implements inspection procedures using appropriate sampling plans to meet company quality plans. • Conducts inspection and production personnel training on quality systems and inspection procedures. • Leads inspection and test method development and assessment activities. • Assists in the support of the company’s internal audit, non-conforming material, and corrective & preventive action systems. • Provides QA support as required. • Designs and develops procedures and processes for recording, evaluating, and reporting quality and reliability data associated with the Product Development and Manufacturing, CAPA, NCR, IQC, Complaints and Lot Release systems. • Compiles and analyzes data and Quality metrics for Management on a weekly, monthly, quarterly, and annual basis. • Maintains up-to-date knowledge in the techniques of Quality Assurance, Quality Systems requirements and in the company products and process technologies. • Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies, and procedures for Class III medical devices. • Supports company goals and objectives, policies and procedures, quality systems, and regulatory requirements, including FDA regulations/MDD/ISO.
Skills and Knowledge
• Knowledge of Quality System Regulations, international standards and Quality System requirements. • Experience in developing: quality plans for new products, component control plans, inspection and testing methods, performing risk analysis (PHA, FMEA, FTA), reliability testing, component qualification, process validation, Design of Experiments (DOE) and applying documentation control and advanced statistical analysis techniques. • Experience in design control, metrology, supplier quality, CAPA management, and quality system auditing. • Demonstrated ability to apply appropriate statistical techniques, including inspection sampling plans, statistical process control, process capability studies, process improvement and verification/validation studies. • Proficiency with advanced analytical problem solving. • Proficient with standard application software. • Good computer skills. • Good interpersonal skills. • Excellent written and oral communication skills.
Education and/or Experience
• Bachelor’s degree in an Engineering or Science discipline is required. • A minimum of ten (5) years’ experience in quality assurance or quality engineering within a regulated medical device industry. • ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) preferred. • Good written and verbal communication skills a must. • Ability to use general office equipment, PCs and associated software.
