Global Non-Conformance Manager Job at Olympus Corporation of the Americas
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Job Description
The Global Non Conformance (NC) Manager is responsible for the Global NC process leadership driving improvements and compliance in product and process performance and elimination of waste. In addition, will oversee the responsibilities for the effectiveness and efficiency of the Global NC process for issue identification from multiple sources e.g., but not limited to Service & Repair/Deviations/In process controls/Audits/OOS/SPC for both product and non-product non conformances where safety and risk decisions for rework, return to vendor, use as is, scrap are executed through timely NC review boards approvals. Act as a change advocate will manage all aspects of NC activities which include gaining the commitment of cross functional resources, ensuring NC deliverables are to timelines, effective solutions are implemented that deliver high quality/safety risk based decisions for the QMS. Develop a plan to bridge improvement gaps between NC vision and current state and implement the plan for an integrated Global NC process and drive standard work in execution at all Global Olympus locations. Accountable for improving the NC process and system for tracking, trending, and reporting; and triggers for CAPAs are identified early and assessed in a timely manner. Defining KPI, robust NC review boards and dissemination of information is managed effectively with key stakeholders. Providing direction to leadership at all locations in scope of the Global Olympus NC program on the continuous cadence on NC process improvements and governance of process measurements driving actions. Develop and implement an ongoing education program for the NC process. This position will support a team of Local SMEs in the execution of NC standards for an effective process. This position will be responsible in ensuring the Global NC process is compliant with Global Olympus policies and all applicable international regulations and standards.
Job Duties
- Responsible and accountable for NC identified sources for timely escalations in the NC process. This includes collaboration with functional teams for local and global compliance of NC procedures to ensure timely escalation, risk product disposition and effective closure of NCs. · Responsible to develop / deliver training on the Execution of the NC global process, incorporating standard work and lean principles that delivers positive audit outcomes.
Defines process measures and reporting structure that drives visibility and action with the Global Olympus network.
Ensures that the NC processes are improved and standardized throughout all Olympus global locations and ensures that NCs are executed to high quality standards with effective governance process that drives risk detection and escalations.
Perform and Improves on monthly / quarterly of data quality driving strong analytics for a defined review process, recorded outcomes and closed loop feedback for local and global NC review boards with the QMS.
Identifying and enhancing Monitoring / Measuring / Analytics for Process and Product controls sources feeding into NCs.
Lead and facilitates in global internal and external Quality Audits (including notified bodies and health authorities) and ensure related NC process and analytic activities are audit ready and any follow ups are completed in a compliant and timely manner.
All Other Essential Duties as assigned by Management.
Job Requirements
REQUIRED QUALIFICATIONS:
BA/BS medical, engineering, scientific discipline Black Belt / Green Belt, Continuous improvement techniques and/or demonstrated problem solving and root cause techniques.
Minimum of 5 years’ experience in a medical device manufacturer with demonstrated results in effective NC process to International Regulations and standards.
Demonstrated experience leading global change initiatives and integrations for multi-site and multi-product businesses through collaboration with the business and effectively interact with and influence teams and managers.
Demonstrated experience in developing and leading skill enhancement of teams demonstrating strong compliance to processes.
Competent understanding of International medical device regulations specific expertise in.
Demonstrated leadership in managing Regulatory Inspections & Notified Body audits.
Strong capability to influence at multiple levels within the organization on NC policy development & implementation.
Mentoring and Coaching of teams.
Demonstrated skill in Strong analytics driving strong risk based decisions that drives escalations within the QMS.
- Competent with ERP systems, Microsoft Office 365 Suite, Visio, Adobe, DocuSign, Agile and Windows platforms.
Up to 25% international travel Proficiency in English and additional Languages preferred e.g., Japanese / German
We realize work isn’t just a job to you.
It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.
Olympus requires all new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.
Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.
Olympus’ Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.
Olympus…True To You. True To Society. True To LIFE.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley ||
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