Quality Engineer II for Process and System Governance Job at Olympus Corporation of the Americas
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Job Description
Support the alignment of the global complaint handling process across Olympus globally with focus on the business process, system tools and master data that supports the efficient and accurate handling of product complaints in all markets. This position will directly lead and/or support continuous improvement and sustaining efforts for the global processes and systems to assure compliance, harmonization, and efficiency.
Job Duties
- Provides executional and where appropriate, strategic guidance to elements for the global complaint handling processes and systems to establish and implement best practices in accordance with US and International requirements.
Identifies and drives continuous improvement activities within the global complaint handling processes and systems through partnership with key functional groups and driving accountability through execution.
Identifies areas of focus through data driven trending and brings solutions to management. This responsibility includes liaising with internal and external parties on matters relating to the organization’s complaint handling processes and systems and the continued development in accordance with changes in Regulatory Agency requirements and Business needs.
Report on the performance of the complaint handling processes and systems to Company management, as directed, for review and as a basis for improvement.
Ensures, through system, procedural and governance improvements that the complaint handling processes and systems are standardized throughout the business. Ensures that they are implemented consistently, correctly and measured through practical metrics.
Ensures timely action and or escalation into the quality management system in accordance to and commensurate with the risk of the trends identified.
All Other Essential Duties as directed.
Job Requirements
REQUIRED QUALIFICATIONS:
Bachelor's Degree in Engineering or another technical field desired.
Minimum of 2 years’ experience working in manufacturing, finished medical device or related regulated industry with manufacturing processes, operational excellence, quality systems, and continuous improvement activities required.
PREFERRED QUALIFICATIONS:
Six Sigma Green Belt and Lean certifications, Six Sigma Black Belt preferred.
Experienced with statistics, sampling strategies, quality systems trending, process capability, including statistical software tools.
Must be self-motivated with a strong sense of urgency to solve issues.
Ability to consistently deliver on required activities and meet assigned deadlines.
Prior experience with active participation in cross-functional teams.
Excellent interpersonal, communication (written and oral), presentation and facilitation skills.
Proficient in PC based applications (Word, Excel, PowerPoint, Project, & Visio), including Agile PLM.
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) || Massachusetts (US-MA) || Westborough ||
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