Danaher Corporation RA/QA Program Manager in Brea, California
Danaher Company Description
For nearly 60 years, Ormco has partnered with the orthodontic community to manufacture innovative products and solutions to enhance the lives of our customers and their patients. Distinguished products range from legacy twin brackets (Inspire ICE™, Titanium Orthos™ and Mini Diamond™) to pioneering the self-ligating appliances with the Damon™ System (including Damon™ Q2 and Damon™ Clear 2). Ormco’s Insignia™ Advanced Smile Design™ provides an all-inclusive customized indirect bonding solution for increased clinical efficiency. From personalized service to professional education programs and marketing support, Ormco is committed to helping orthodontists achieve their clinical and practice management objectives. For more information, visit www.ormco.com.
The focus of the RA/QA Program Manager will be leading the Quality/Regulatory facing actions necessitated by the change in Corporate and Legal Manufacturing address to the Brea, CA facility. This position will lead the business unit-specific cross functional project teams to ensure the appropriate risk/program management activities are executed in harmony to protect the end customer and company compliance to FDA/International medical device standards.
Reporting to the Vice President, RA/QA, the Program Manager will be responsible for managing strategic planning and execution of all aspects of “Polaris” projects, with particular emphasis on RA/QA budget estimations, requests, and cost management.. This will include responsibility for managing project outcomes to achieve objectives on-time and within budget. The Program Manager will need to be detail-oriented and an excellent communicator with strong leadership skills. He or she will be responsible for coordinating project communications and deliverables, planning, and execution. The ability to meet capital budgets and deliver high levels of quality and service will be essential. Relationships with key internal business partners and related reporting needs are a further critical aspect of this role; including with Purchasing, Legal, Inventory Management, Distribution, R&D, Manufacturing, Marketing, Quality, , Global Sourcing and Accounting and Finance.
Essential Duties and Responsibilities: * Responsible for all aspects of project management for assigned projects, including, but not limited to: chartering, scoping, requirements gathering, document approval tracking and management, project plan creation, status reporting, issue resolution, project resource allocation, project costs and financial analysis, and benefits validation. * Creates cohesive project plans with identifiable critical path, task dependencies, and major milestones, and manages the approved plans and schedules, ensuring successful completion within scope, budget, time, and quality parameters utilizing the Danaher Visual Project Management format. * Ensures coordination between BU-specific labeling and design document remediation project teams to meet international registration deadlines and internal MDD/MDR/ROW/CAPA action requirements. * Works closely with Operations to define the timing of labeling transitions and development of bridge inventory builds where needed * Works closely with Supply chain/Legal to ensure MDR requirements are incorporated into procedures/processes and contracts. * Works closely with Quality department to ensure MDR requirements are incorporated into our Quality Management System procedures/processes. * Builds business cases to identify/present portfolio rationalization opportunities to Product Management/Marketing. * Introduces lean concepts and DBS principles to the RA/QA organization to accelerate the cadence of project execution and deliverables, in addition to building team problem solving capabilities and culture. * Sets deadlines, assigns responsibilities, monitors and summarizes progress of projects. * Prepares reports for upper management regarding project status. * Builds and maintains effective working relationships with team members, and other departments involved in the projects. * Leads and coordinates the work, priorities, and schedules of Core Team project management and extended team members. * Supports team members in executing tasks as needed to meet project deliveries. * Coordinate meetings, writes minutes, updates budgets, manage presentations.
Essential Background, Qualities, Duties and Responsibilities: Candidates must have the proven ability to lead a team of professionals who can interact across all levels and functions of the organization effectively. Candidates must also bring to this position a proven ability to lead during a time of significant growth, and an ability to establish credibility and influence other executives through both formal and informal leadership.
Additional professional and personal requirements include: * 5 or more years of combined QA/RA related experience required. * Proficient in MS office suites, MS Project and Visio. Sharepoint. * Excellent time management and follow-up skills. * Detail-oriented and demonstrated ability to effectively manage multiple priorities simultaneously and meet critical deadlines in a fast-paced environment. * Excellent verbal and written communication skills with a demonstrated ability to professionally represent the project status to Steering Team * Strong initiative and ability to be self-directed in completing tasks and function with minimal supervision. * Strong problem-solving and analytical skills. * Excellent teamwork and interpersonal skills. * Demonstrated ability to be flexible and adaptive to internal processes and change, delays or unexpected events. * Ability and willingness to work extended hours, including overtime and weekends * Desired * Kaizen and/or Six Sigma * BS Degree in Business Management, Operations, Logistics or Finance with Engineering coursework viewed favorably.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.
Job Function: Quality and Regulatory Affairs
Primary Location: North America-North America-United States-CA-Brea
Req ID: ORM001725