Quality Systems Engineer

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Job Description SummaryReporting to the Director of Quality, this role develops and implements effective data analysis and visualization for all of Post Market Surveillance and Quality Management Systems (QMS) within and support of BDB business. These activities are in direct support of monitoring and detecting quality and safety signals associated with product performance (e.g., adverse events, product malfunctions) as well as QMS performance. This role ensures on-going regulatory compliance and continuous product and QMS improvement.Job DescriptionValues – Our Standard of BehaviorWe do what is right We thrive on innovation and demand qualityWe are all accountableWe learn and improve every dayWe help each other be greatOur Mindset – The attitude we bring to our workSpeaking up builds trust and gets to better outcomes fasterInclusion and diversity make us a stronger teamKeeping it simple enables innovation and agilityThe best way to help customers and patients is to truly know themChallenges are opportunities to grow and improveLeadership Commitments – How we lead ourselves and our workBe bold and strategicRemove obstacles and empower othersDeliver results that matterDebate and decide, then commit and goHave the courage to iterate, try new things and embrace changePRIMARYRESPONSIBILITIESCollect and Analyze Quality Data to assist with Management Review content development, CER, PMS, Quality Scorecard, etc.Assures the data integrity of all output via appropriate verification and validation activities. Ability to document statistical-based trending procedures and trending analysis validation in compliance with regulatory requirements Support Post Market Surveillance providing data and supporting the preparation of Post Market Surveillance reports and plans for submission to regulatory bodies.Interface with other functions to ensure accurate and timely completion and review of documents.Conduct comprehensive literature searches, review of complaints, corrective and preventive actions, and MAUDE database and summarize in a report for medical devices.Actively participate in quality guidance and helps project & quality network teams for process improvement and continuous improvement activitiesProvide guidance and training to sites in Analysis of Quality DataSupports quality system improvement and standardization initiatives within BDBSupport internal and external audit/inspection for area of responsibilitiesEDUCATION AND EXPERIENCE REQUIREMENTSKnowledge of US and International regulations and standards that apply to the medical device industry including FDA Quality Systems Regulations, ISO 13485, MDD, EU MDR/IVDR, Canadian MDR, Japan PMDA as well as ANVISA and TGA requirements.In-depth understanding of the application of quality systems to the medical device industry.Experience with Trackwise and SAPAdvanced proficiency in data analysis tools such as Excel, Qlikview and BI report preferred.Excellent communication skills at all levels both written and verbal.Ability to set and deliver to specific goals and targets.Ability to perform multiple tasks and prioritize workload.Effective analytical, technical, and problem-solving skills.Effective meeting and presentation skills.Effectively manage conflict.Ability to work in or direct teams to obtain results.Self-motivated /directed.Typically requires a minimum of a Bachelor’s Degree (preferred Life Sciences or Engineering)Industry Recognized certification in a Quality System Element specialty  (e.g ASQ Certified Quality Auditor, Quality Manager, Quality Engineer) preferredA minimum of 5 years of relevant experience or a combination of equivalent education and relevant experience.  Primary Work LocationUSA CA - San JoseAdditional LocationsWork Shift

Company info

C. R. Bard, Inc.
Website : http://www.crbard.com