Quality Engineer
3 weeks ago
Description: This position will be responsible for analyzing and resolving production issues by collaborating with engineering and material procurement teams. They will conduct monitoring of process data, analyze trends, financial results, and customer feedback. They will demonstrate a commitment to a quality-first culture, compliance, and continuous improvement by implementing projects that optimize production, inspection, and quality system processes. Essential Duties and Responsibilities Production Quality Management - Issue Analysis and Resolution: Conduct thorough root cause analysis of production issues, establish suitable containment, and lead corrective actions. * Collaborate with Design Engineering, Regulatory, and Manufacturing Engineering to perform risk assessments on non-conformities detected in manufacturing. * Work with division and manufacturing engineers, as well as materials teams, to foster collaboration and communication for resolving issues. * Track and analyze production performance trends against key quality metrics and set appropriate control measures. * Promote the detection and prevention of non-conformities to enhance business outcomes by reducing scrap and rework expenses, ensuring a positive customer experience. * Engage in activities related to the investigation and resolution of customer complaints. Production Quality Management - Process Improvement: * Assess and enhance quality inspection techniques and tools to increase the reliability and consistency of incoming, in-process, and final quality control. * Review production and inspection equipment, processes, and protocols to verify precision and adherence to regulatory and quality system standards. * Implement necessary modifications to procedures. * Evaluate the risks related to non-conforming inspection equipment and address the impact on the product. Operations and Quality Control (QC) Efficiency: * Expedite the resolution of Material Review Board (MRB) issues to decrease the number of components/products in MRB. * Enhance Stryker's incoming, in-process, and final QC inspection strategies/requirements/fixtures to effectively identify defects at early production stages. * Guarantee prompt resolution of non-conformances and product shipment holds. * Collaborate with Operations and Division engineering to devise solutions for non-conformances. * Engage in validation activities. * Serve as the Supplier Quality resource in collaboration with Strategic Sourcing and Purchasing. * Facilitate supplier change processes and encourage supplier enhancements. Continuous Improvement: * Identify and spearhead the implementation of enhancements to processes, procedures, and systems. Examples include improving the component qualification process, refining the skip lot process, and updating the supplier change process. * Take the lead on, or assist with, Corrective Action Preventive Action (CAPAs) initiatives that affect the Quality System or product quality, with a focus on enhancing reliability. * Offer assistance during both internal and external audits as needed. Skills: Quality assurance, Root cause analysis, Capa, Iso 13485, Quality engineering, Corrective action plans, Medical device, Ppap Top Skills Details: Quality assurance,Root cause analysis,Capa,Iso 13485,Quality engineering,Corrective action plans Additional Skills & Qualifications: Skills/Roles: Additional Job Details: * Excellent analytical, interpersonal, and organizational skills. * Effective interpersonal communications skills. * Possesses understanding of core process methodologies and problem-solving techniques. * Possesses ability to understand engineering drawings. * Drives for results through timely decision making and the ability to prioritize, plan and measure work. * Resolves conflicts and disputes by addressing multiple viewpoints to develop a mutually satisfying outcome. * Possesses the ability to influence, motivate, and enable others to contribute to the effectiveness of the organization; uses direct persuasion to convince and influence others. * Possesses the ability to interact with diverse internal customers in an effective manner. * Communicates information verbally and in writing in the appropriate language and format according to the audience. Must be able to generate, follow and explain detailed quality requirements and inspection procedures. * Must be able to plan, organize and implement multiple concurrent tasks. Experience Level: Intermediate LevelAbout Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
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