Location: Brooklyn Park, MN
Company: Olympus
on making people’s lives better for over 100 years. Our Purpose is to make people’s lives healthier, safer, and more fulfilling. Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View We deliver on our purpose and our core values by staying True to Life.
Job Description The Senior Manager Quality Data Analytics Global QMS is responsible for analyzing and interpreting quality metric data relating to products, processes and sites. This role will determine requirements to provide standardized data sets to support presentations and review of data by top management. This role will also determine requirements for reporting. This role will partner
close with other Quality and cross-functional leaders at site and global levels to analyze data related the Quality Management System and enable a timely completion of inputs to the Quality Management Review.
Job Duties Identify requirements for quality metric data for Quality Management Review and works with cross-functional stakeholders to develop solutions Oversee the management the use of quality metric data into Quality Management Review Uses quality metric data to analyze, interpret and identify trends from over 100 sites Identify gaps and areas for actions, including a heat map for data Coordinates content for Quality Management Review across site and global level including data
from site level reviews Performs ad hoc queries to analyze trends on metrics or processes Takes initiative to analyze data from tiered or site level reviews for escalation Follow-up and tracking of outputs and actions for completion Supports the creation of content for the Global Quality Management Review Communicate with each site to promote and select escalated data for the global Quality Management Review Develops and fosters working relationships with colleagues globally to drive standardization, collaboration, and support growth across Olympus.
· Participates in Quality initiatives as a cross functional contributor. Demonstrate operational excellence and ensure quality in all deliverables.
Supports CAPA investigations & audit requests (internal & external) Support audits as a Subject Matter Expert for data analytics relating to Management Review, as required. All other duties as assigned. Job Qualifications Required: Bachelor Degree required or demonstrated equivalent professional experience. Minimum of 10 years Quality Management System experience in a medical device or pharma or other regulatory controlled industry (medical device is preferred). Experience in data analysis, trending and presenting data in a manner to drive informed decision making.
Excellent understanding and working knowledge of appropriate global regulations, requirements and standards such as ISO 13485:2016, ISO 9001:2015 and FDA Quality System Regulation Having the global viewpoint to establish and maintain the QMS compiled with global requirements. Travel to other facilities/locations may be required, up to 10% Preferred: Strong attention to detail Ability to operate efficiently, proactively and effectively in a fast-paced environment Good verbal and written communication skills, with the ability to interact with all levels of the organization Well-developed problem-solving skills/ Strong computer skills #LI-Remote Why join Olympus?
Here, people matter—our health, our happiness, and our lives. Competitive salaries, annual bonus and 401(k) with company match Comprehensive Medical, Dental, Visions coverage effective on start date 24/7 Employee Assistance Program Free virtual live and on-demand wellness classes Work-life balance supportive culture with hybrid and remote roles 12 Paid Holidays Educational Assistance Parental Leave and Adoption Assistance Volunteering and charitable donation match programs Diversity & Inclusion Programs including Colleague Affinity Networks On-Site Child Daycare, Café, Fitness Center US Only Limited locations We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you.
Learn more about our benefit offerings at /careers/benefits-perks. About us: Our 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 costs, and enhance the quality of life for patients and their safety.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit . Olympus is dedicated to building a diverse, inclusive and authentic workplace We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect.
We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive. Let’s realize your potential, together. 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, interaction (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, interactionual 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) Minnesota (US-MN) Brooklyn Park Quality & Regulatory Affairs (QA/RA)
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Management & Executive Jobs refer to positions within an organization that involve overseeing operations and making strategic decisions to guide the company towards its objectives. These roles are characterized by leadership responsibilities, high-level planning, and typically require extensive experience. Executives set the vision and goals, while managers ensure that daily activities align with these directives. Such positions often demand strong communication and interpersonal skills, as well as the ability to solve complex problems and adapt to changing business environments.
Management & Executive Jobs encompass a range of high-level positions within organizations, typically involving the responsibility for strategic planning, decision-making, and leading teams or entire departments. Individuals in these roles are expected to possess strong leadership skills, the ability to think critically and strategically, as well as excellent communication abilities. Executives often have a significant influence on company culture, operations, and financial success. These roles include titles such as CEO, CFO, COO, Managing Director, as well as various managerial positions across different departments such as sales, marketing, human resources, and more.
