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    Head of Compliance Operations - San Jose, CA, United States - Olympus Corporation of the Americas

    Olympus Corporation of the Americas
    Olympus Corporation of the Americas San Jose, CA, United States

    3 weeks ago

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    Description
    Olympus, a leading medical technology company, has focused on making people's lives better for over 100 years.

    The Director of Quality, San Jose Operations is responsible for GMP Operations of the facility inclusive of manufacturing quality, repair quality, distribution quality, quality inspection and quality systems.

    This role will ensure quality systems and processes are established, maintained, and continuously improved to consistently deliver right first-time quality, safeguard patient safety, and ensure customer satisfaction.

    The Director of Quality will ensure that sethe site is inspection ready at all times, manage and facilitate site audits and inspections, lead execution of commitments to regulators, and ensure that quality and/or compliance issues are corrected in a timely manner.

    This role will lead site initiatives aimed at building and sustaining a strong culture of quality and will work collaboratively with other functions at the site to achieve quality and business objectives.

    This position serves as the default Quality Management Representative for the San Jose site.

    This position reports into the Quality organization directly and also reports indirectly to Top Management at the San Jose site.

    Leadership of the Site Quality organization and serves as site quality management representative

    ensuring efficient and flawless execution of quality systems and processes to ensure product quality and compliance with global and site policies and procedures, FDA regulations, and other applicable regulations, standards and guidance.

    In accordance with established budget, builds organizational capability and capacity to meet both the current and future needs of the business through talent acquisition, employee training / development and performance management.

    Directs activities to ensure that the site is in a continued state of compliance and inspection readiness including analysis and evaluation of data and presentation to senior management to ensure that projects are appropriately prioritized in alignment with regulatory requirements and business goals.

    Hosts external regulatory inspections and audits and ensures successful outcomes through inspection readiness activities, inspection management and observations resolution.

    Promotes awareness of regulatory requirements and expectations and ensures understanding of quality system requirements across the site. Identifies site training needs and leads efforts to ensure effective training delivery.

    In accordance with quality system and technical requirements and risk management documents, ensures implementation of effective process controls for manufacturing, servicing and supply chain operations that support timely delivery of products that consistently conform to their specifications.

    This includes validation and maintenance of the Site Master Validation Plan, calibration, equipment maintenance, critical component evaluations, and quality inspections.

    Anticipates and identifies quality and compliance risks and proactively collaborates with Operations and Supply Chain leaders to identify potential areas of process and product variability.

    Implements controls to prevent escape of nonconforming product, drives timely and thorough root cause investigations for quality issues (e.g., NCs, customer complaints), and ensures implementation of effective corrective and preventive actions (CAPA) to mitigate recurrence of quality problems.

    Acts with appropriate levels of urgency commensurate with risk and escalates issues to management.
    Lead complex investigations to identify causes of problems to safeguard patient safety and business continuity.

    Utilizes data to assess the overall health and effectiveness of the site's quality system and processes and identifies areas to improve efficiency and effectiveness.

    Maintains budgetary oversight for the Site Quality Operations organization.

    Partners with Finance and Operations business partners to ensure that expenses, headcount and capital are in alignment with business goals, financial targets and strategic plans.

    Engage in a positive manner with team members from all disciplines to enhance the culture of quality and maintain a patient and customer focused quality mindset.

    A minimum of 10 years of cGMP experience in quality management (with direct shop floor experience) within the MedTech industry.

    Experience with durable medical devices, and a strong understanding of repair operations and servicing requirements to ensure they continue to meet safety and performance specifications over their usable life.

    Demonstrated experience influencing senior level management and key stakeholders and leveraging cross-functional partnerships for successful execution of critical quality initiatives.

    Experience interpreting and applying business requirements and regulations (FDA and other applicable global authorities) into sustainable quality processes leveraging industry best practices.

    Advanced technical degree and/or MBA preferred.
    Lean Six Sigma Black Belt Certification desired.
    Proactive approach to quality and compliance, with a focus on innovation and adaptation in a fast-paced environment.

    Strong ability to think and act globally, be fearless change agent while managing risks, develop future visions and engage audiences to drive transformation.

    Capable of presenting clear and insightful thoughts based in facts and data gain trust, build confidence and to influence key stakeholders across the business.

    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
    ~ Diversity & Inclusion Programs including Colleague Affinity Networks
    ~ On-Site Child Daycare, Caf, Fitness Center***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. The anticipated base pay range for this full-time position working at this location is $154,188.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.

    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.

    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.


    Applicants with Disabilities:
    As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone.

    If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at .

    If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus

    Posting Notes:
    || United States (US) || California (US-CA) || San Jose || Quality & Regulatory Affairs (QA/RA)
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