Job Description

Your Job: The Sr Quality Engineer - Compliance & Audit Programs p rovides high-level Quality and Regulatory Compliance leadership and expertise for Kimberly-Clark Corporation\'s Quality Compliance and Audit Programs. The role is responsible for planning and conducting audits and work ing with the audited sites to ensure compliance with domestic and international regulations, corporate policies and procedures, and local procedures. Brings and maintains subject matter expert ise in both emerging , changing and current regulations applicable to Kimberly-Clark Corporation. In your Sr Quality Engineer - Compliance & Audit role, you\'ll help us deliver better care for billions of people around the world. About Us: People have looked to Kimberly-Clark brands for more than 150 years and today we\'re proud to help over a billion people around the world cope, laugh, love and live every day. From the best nappies and baby wipes to the softest tissues, to the best supplies for business, we are constantly searching for new ways to make life better for our consumers, our customers and our planet. Our leading consumer brands like the Kleenex, Huggies, VIVA, U by Kotex, Poise, Depend brands improve the lives of people around the world.Kimberly-Clark proudly leads the way in providing better care for a better world. Role Overview & Primary Accountabilities: Lead Quality and Compliance Audits to assure compliance with domestic and international standards and regulations, corporate policies and procedures and local procedures. Takes leadership role in the development of auditee communication, audit plans, conducting audits, review of audit responses for adequacy, and monitoring of quality improvement plans for K-C sites Enterprise-wide and supplier sites as requested. Follow up with the audited site as required to compile information related to the audits . Evaluate the adequacy of the provided evidence against the approved audit quality improvement plan . In conjunction with management develop plans to address inadequate audit improvement plans when required. Maintain the audit system software database to record the status of all audits and associated actions. Provide periodic reports to management based on the audit status and metrics. Accountable to establish and maintain assigned elements of the Quality Compliance Audit Program such as procedures, guidance documents and forms which make up the program . M aintain the audit database to monitor audit p erformance metrics and prepare reports for management. Develop and deploy education and training to the internal a udit n etwork who act as secondary auditors as well provides education and guidance for the site team members and site management. Provide expertise and guidance in interpreting and applying policies, standards , governmental regulations, and internal regulations to assure compliance. Ensures conformance to the audit program standards . Develops standardized approaches aligned with industry best practices in quality management, including, but not limited to Auditing and Quality Metrics. Leads quality system improvement programs enterprise-wide to establish and improve Quality Management System elements such as Auditing to ensure business, facility and corporate objectives are met. Maintains comprehensive knowledge of applicable regulatory requirements and interpretation. Provides regulatory compliance expertise by sharing external regulatory environment, industry trends as well recommending actions to address any potential impact to the enterprise. GENERAL EXPECTATIONS AND ACCOUNTABILITIES Manage self in accordance with the expected One K-C Behaviors. Influence and recommend new quality concepts, tools and strategies for the enterprise Quality organization. Builds capability in self by maintaining and demonstrating a high degree of knowledge and skill in quality management systems , process es and regulations. Builds and maintains strong relationships and networks with key stakeholders and peers within the business unit, across the enterprise, and across industry. Establishes and maintains collaborative relationships while driving solutions to meet business needs. Develops and maintains a strong spirit of partnership. Conduct all communications and transactions with the utmost integrity, consistent with the KC Code of Conduct. Communicate effectively with Senior Leaders, Peers, Functional Partners. WORKING CONDITIONS: Travel up to 50 % of the work time domestic and international , no rmally 25 - 33% . Work is completed in both office environments and at Manufacturing Facilities and/or Laboratories. When at Manufacturing facilities or Laboratories, will be exposed to environments ranging from dust, heat, noise, moisture up to clean room / laboratory environments. Proper personal protective equipment (PPE) must be worn at all times (may include safety glasses, facial protection, ear protection, hair nets, beard bags (if applicable), full gowning Essential Requirements: Basic Qualifications A Bachelor\'s degree in Engineering, Biology, Chemistry or equivalent degree. 8 + years of experience in the Quality organization in a medical device or pharmaceutical environment . A minimum of 5 + years of experience with auditing compliance to domestic and international regulations for medical devices , pharmaceuticals or cosmetics . A recognized quality management qualification is desirable such as ASQ Certified Quality Auditor , Lead ISO 13485 Auditor or CQI Chartered Quality Management Professiona l Proven ability to communicate in written and spoken English . Preferred Qualifications A minimum of 5 years developing and deploying, efficient and effective quality management system elements and processes, preferably across multiple geographic regions. Experience in an organization with Quality as a compliance function. Demonstrated understanding of Medical Devices, Consumer Products, and Cosmetic regulations across the globe. Thorough understanding and experience interfacing with regulatory bodies across all regions. Understands and can apply industry-standard practices such as Good Manufacturing / Warehouse Practices (GMP & GWP) Demonstrate understanding and impact of industry trends, emerging regulatory compliance requirements and best practices via internal/external benchmarking for integration considerations into business specific quality strategies. Understanding of key regulations and standards applicable to K-C specifically related to medical devices as a consumer product. Expert k nowledge and experience in CAPA Root Cause Investigation Validation (Process, Test Method, Software, and Design) Excellent verbal , written communication and analytical skills Knowledge and ability to apply international standards and regulations of 21 CFR Part 820, 21 CFR Part 11, MDSAP, EU MDR, EU MDD, ISO 9001, ISO 13485 , ISO 22716 Ability to anticipate and meet deadlines, handling multiple simultaneous deadlines, prioritizing work, strong attention to detail, and the ability to retain confidential information. Collaborative, responsive, action-oriented and innovative problem solver About You: You\'re driven to perform at the highest level possible, and you appreciate a performance culture fueled by authentic caring.You want to be part of a company actively dedicated to sustainability, inclusion, wellbeing, and career development. You love what you do, especially when the work you do makes a difference. At Kimberly-Clark, we\'re constantly exploring new ideas on how, when, and where we can best achieve results. When you join our team, you\'ll experience Flex That Works: flexible (hybrid) work arrangements that empower you to have purposeful time in the office and partner with your leader to make flexibility work for both you and the business. What\'s on offer: Our Kimberly-Clark employees receive a competitive salary and incentives as well as access to a fantastic range of benefits including superannuation, career development opportunities, free health & well-being activities, volunteering leave and much more. To Be Considered: Click the Apply button and complete the online application process. A member of our Talent Acquisition team will review your application and will be in contact with additional information accordingly. In the meantime, feel free to browse our website for additional information on our company, brands and culture - . Kimberly Clark is proudly accredited with as Employer of Choice for Gender Equality WGEA!

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