Product Quality Engineer II

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Location :
Warwick, Rhode Island

Expiry Date :
Sun, 06 Dec 2020 23:59:59 GMT

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Job_Description Job Description Summary Represent quality on product portfolio sustainment teams and assure that current product designs and the processes for manufacturing and distribution meet all Corporate and Divisional requirements with respect to safety and efficacy. Be an active team member and cross-function collaborator on product lifecycle sustainment and product/process enhancement project teams for implantable medical devices. Be an active team member for proactively improving process quality, conducting change management, investigating quality events, examining non-conformances and executing CAPAs. Product_Design * Provide Technical guidance to Quality Engineers, Quality Technicians, Inspectors, and cross functional counterparts. * Develop Test Protocols and Final Reports to support Regulatory 510K, PMA, CE mark and International registrations. * Support activities for continuous process improvement and production continuity. * Lead Quality Engineering Projects to improve Quality systems and Procedures. * Maintain design risk assessments, coordinating input from the other Sustaining Sub-team members, and manage overall risk files for devices. * Assess historical Design Verification Protocols and the subsequent Final Design Verification Reports including an analysis of all data and a decision on design acceptability for design and process changes. * Assess historical Design Validation Protocols and the subsequent Design Validation Reports including an analysis of all data and a decision on design acceptability for design and process changes. * Assess and maintain the product Design Input Summary (DIS), Product Performance Specification (PPS), Product Development Plan (PDP), and applicable design history documents as defined per Davol s product development process. * Determine the degree of Biocompatibility testing required as per ISO10993 and company procedures. Co-ordinate the testing at an outside lab and document results. * Develop or assist in development of inspection and test methods per product specifications. * Perform test method validations to ensure accuracy, precision, selectivity, sensitivity, stability, and reproducibility of analytical or physical test methods used to assess the safety and efficacy of devices. * Develop shelf life and stability test protocols and reports as required. Process_Development * Maintain and improve the Control System for the manufacture, sterilization and distribution of existing products including Inspection Plans for the inspection of components, sub-assemblies and final product. * Monitor and maintain manufacturing control plans for internal and outsourced processes. * Support (or lead) development of process risk assessments. * Perform and/or support Process Development Studies to determine the acceptability of new processes or equipment. * Design and qualify inspection test methods and equipment. * Provide Quality Engineering Support to outsourced analytical laboratories and manufacturing facilities to ensure compliance with applicable requirements of 21CFR 820, 210, 211; cGMP s, and ISO13485:2003 requirements. * Lead supplier part qualification activities including mold qualification and DOEs. * Support Process Transfers to the Production facilities. Other * Make dispositions of rejected nonconforming components and products; conduct MRB action when required. * Monitor and supervise proper change controls for design and process improvements. * Organize and generate detailed quality information reports to show trends and the impact of process improvements. * Support Process Transfers to the production facilities. * Conduct other Quality Control Projects as assigned by the Manager of Advanced Quality Engineering. * Support the development and effective implementation of Corrective and Preventive Action Plans to resolve quality non-conformances. * Perform DOEs and other statistical analyses to support product and process optimization or determine causes of process variation. Initiate corrective actions as required. * Monitor Product Quality indicators and statistical process controls for product health assessments. * Provide technical support and disciplined root cause analysis to resolve quality problems in manufacturing, distribution or with suppliers as warranted. * Support formal investigations and Field Action recommendations as warranted. * Support goals of the Quality Assurance Department. * Special projects as assigned. Requirements * Bachelor Degree in Engineering or Technical Sciences. * 3 years minimum experience with Bachelor Degree or 2 years minimum experience with Master s Degree in Engineering or related discipline including design controls, product/process validation, risk management, and technical problem solving. * Experience working in a regulated industry * A high level of competence in Quality Technology including statistical techniques, control charts, sampling plans, Quality costs, design of experiments, correlation and regression, analysis of variance, probability. * Strong Design Control understanding from concept to launch; especially in post-market activities (including complaints, failure investigations, and CAPAs). * Applied Knowledge of the requirements of FDA QSR, ISO13485and ISO 9001. * Prior experience in manufacturing environment a plus * Prior experience with combination products and absorbable technologies a plus. * Prior experience as a quality engineer lead on new product development teams a plus * Prior experience interacting with Surgeons a plus. * Good oral and written communication skills. * Must be willing to travel (domestic & international). Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status. a strong drive for results. Primary Work Location USA RI – Warwick Additional Locations Work Shift Job Category: Engineering Show moreShow less