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Sr. Quality Engineer (RoHS Compliance)

Company: Pall
Location: Westborough
Posted on: September 25, 2022

Job Description:

Find what drives you on a team with a more than 70-year history of discovery, determination, and innovation. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers protect people. Our products serve a wide range of markets, so if your interests lie along the spectrum of Life Sciences to Industrial, you'll find a rewarding role here. For the exponentially curious, Pall is a place you can thrive and amplify your impact on the world.Pall is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we're pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.R esp on s ibilit i e s & Accountabilities: Regulatory compliance Sr. Quality Engineer will be responsible for ensuring product sold by the Westborough facility is in compliance with European Union regulations (RoHS3, REACH, WEEE, etc), UKCA, RoHS2, Prop-65, UL listing and CE marking. Ensure all associated technical documentation is aligned with the regulatory requirements for products on the market and products to be placed on the market. Support new product development and subsequent release of product to market as quality representative. Support global regulatory officer and global quality team as needed. Fronting and supporting of onsite/virtual audits from customer and regulatory bodies including relevant preparation, responses to audit findings and facilitation of action completion inclusive of creation of audit records in Smart Solve system. Quality Management System Compliance and Analysis Working closely with the Quality Assurance Manager, develop meaningful management reporting of QMS trends and associated corrective actions on periodic basis that summarizes review of trends/ patterns, potential system deficiencies and bring these to the attention of senior leadership as necessary. Publish quarterly product quality trend report communicating quality trends by product family and customer. Support development of Internal auditing compliance program to ISO9001:2015 with Quality Assurance manager. Support development of daily visual management for the quality organization Track and trend data for monthly reporting Evaluate DVM data for opportunities for improvement Manage efforts associated with the overall process flow/ logistics of the electronic data management system for Quality Documentation, Corrective/ Preventative Action, which includes elements such as timeliness of actions through the system, operating efficiency, and quality system compliance to ISO guidelines/ FDA Quality Systems regulations, including electronic records Support Supplier Management for PASS Support Global Supplier Quality Manager for maintaining supplier performance data regionally. Establish supplier improvement plans and/or continuous improvement plans with the support of the Global Supplier Quality Manager. Conducting supplier audits including relevant preparation, creation of audit reports and records within the Smart Solve System, and monitoring for completion with support from Global Supplier Quality Manager. Evaluate and trend supplier related NC's, CAPAs, and complaints. Publish trends on a quarterly basis. Support customer factory acceptance testing as well as third party visits and approvals. Support engineering in supplier FAT/Tank reviews Q ua l i f ic a ti o n s/ E du c a t io n: Bachelor's Degree in Engineering disciplineExperience : Prefer 2-4 years of experience in a Quality role Supplier management experience including selection, auditing, approval, and monitoring. Knowledge of the ISO 9001:2015 standard Knowledge of regulatory requirements for Latin America and North America. Knowledge of regulatory requirements for UK, European Union, and Asia Pacific a plus. Internal and external QMS audit experience. Experience with QMS documentation, CAPA and audit documentation tools.#LI-ND19 #bestteamwins#pallproudWhen you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation. If you've ever wondered what's within you, there's no better time to find out.

Keywords: Pall, Worcester , Sr. Quality Engineer (RoHS Compliance), Engineering , Westborough, Massachusetts

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