Danaher Corporation Director Quality Management System Improvement & Special Projects in Brea, California
Purpose of Position:
The primary function of this position to provide strategic direction and tactical planning and execution to support the Danaher Corporate RAQA function (with primary support to the medical device regulated business) on enterprise-wide initiatives and special projects, with a focus on Growth & Innovation (with a goal of supporting the RAQA function as a competitive advantage), Risk Management (developing and implementing efficient and compliant risk-response processes), and DBS Integration (using DBS to implement the foregoing). Additional responsibilities include the development and execution of various initiatives to quality and regulatory processes, structures, and systems to drive continuous improvement in support of regulatory compliance and achieving strategic and policy deployment objectives through the effective application of DBS fundamentals.
Essential Duties and Responsibilities:
Responsible for planning, development, and execution of certain enterprise-wide programs to support Danaher’s quality and compliance strategies. This role will interface across multiple business units, regions and functions to drive programs and initiatives that ensure improvements to quality systems and compliance
Maintains effective partnership with department, function, OpCo, platform, and Danaher L1 and L2 leadership. Utilizes effective relationships to actively solicit feedback on quality program effectiveness and site support needs. Develops short- and long-term strategic plans for improvement and associated action plans and metrics.
Support goal of establishing Quality and Regulatory as a competitive advantage as part of 5-year strategic objective, by creating and implementing strategic and tactical plans around developing department growth preparation ability, agility, and scalability
Creates and implements effective risk management strategies and improvement, including through the development of standard work, analysis, trending, and reporting, and utilizing the Danaher Connect Team site for increased efficiency to support growth & innovation.
Initiate, lead, and facilitate quality improvement and strategic initiatives through the effective application of Danaher Business System (DBS) Tools. Includes achieving and maintaining Certified Practitioner status for key DBS tools including, at minimum, Transactional Process Improvement (TPI) and Visual Project Management (VPM)
Direct the quality & regulatory affairs functions within Danaher MedTech businesses as assigned on either a temporary or ongoing basis
At the request of the Director Corporate RA/QA Compliance, provide support for upcoming regulation changes to ensure audit program preparedness and compliance with upcoming regulation changes globally.
Develop, execute and manage action plans in support of quality systems related strategic objectives and improvement projects.
At the request of the Director Corporate RA/QA Compliance, perform internal audits for the Danaher regulated facilities to the applicable regulations in support of new acquisitions or targeted site compliance needs
Ownership of the Corporate RAQA escalation processes for recalls and adverse events. Provides tracking, trending and analysis to identify global improvement opportunities to support strategic initiatives
In collaboration with department management, define and execute department strategic and tactical plans to support department growth, agility, scalability, innovation and technology improvements
Assist in RAQA due diligence assessments of potential acquisitions and in integration post acquisition to ensure Danaher’s high standards of compliance
Develop and roll-out training programs, workshops, and webinars for RAQA and other functional leaders and team members
Strong bias for results and continuous process improvement
Demonstrated experience managing corporate or global initiatives
Experience in driving change management initiatives across an organization, ability to establish and build psychological safety and a foundation of trust as a basis for change management
Proven project management skills, VPM ACP preferred
Strategic thinking capability, proven ability in dealing with ambiguity
Strong influence management at various levels across the organization
International business experience
In depth working experience with FDA 21 CFR 820, ISO 13485, 14971, MHLW, CMDCAS, TGA, ANVISA, MDSAP, MDR, IVDR. Extensive quality systems and sound regulatory program management knowledge.
Must be able to manage controversial issues that may arise through constructive communication with cross-functional teams. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily and it will require approximately 30% - 50% travel (domestic and international).
Education and/or Experience:
Bachelor's degree (B. A. or B.S.) in a science discipline from a four-year college or university; and a minimum twelve years related experience and/or training; or equivalent combination of education and experience. Must have direct experience and knowledge in FDA 21 CFR 820, ISO 13485, 14971, MHLW, TGA, ANVISA, MDR, IVDR, MDSAP.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.
Danaher Corporation and all Danaher Companies require all US and Puerto Rico employees to be vaccinated against COVID–19 as a condition of employment, subject to reasonable accommodation as required by law.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at email@example.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.