At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.
Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.
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which makes everything possible.
*In this role, you will have the opportunity to:*
* Responsible for the Change Control release of all Change Orders for the organization. Establishing systemic process for review Change Orders in accordance with industry standard GMP practices. Supervise direct reports responsible for Change Order review and processing. Provide guidance on GMP guidance and educate reports on best practices
* Supervises direct report(s) to ensure all eDHR are reviewed and that changes are properly documented and structured. The objective of this task is to effectively reduce the department’s turnaround Time to Market and provide high level support to Manufacturing Staff.
* Oversee and management of the company’s Quality System Framework and Process Ownership of Quality System elements
* Ensure management and maintenance of all Quality System elements to meet company’s business needs, developing company best practices, standards, and continuous improvement, and ensure compliance to regulatory requirements and standards
* Ensures proactive compliance to all applicable internal, domestic and international quality regulations US 21 CFR 820 (QSR), ISO 13485, etc.
* Establishes and maintains policies and procedures to ensure compliance with local, state and federal environmental regulations and standards including compliance with all Food & Drug Administration (FDA) and European Union Medical Device Directives (MDD) as well as all other applicable global regulatory requirements.
*The essential requirements of the job include:*
* Bachelor’s degree with 5+ years of related work experience
* Able to apply business understanding and technical expertise and full knowledge of other related disciplines to assist in solving complex technical and business issues; Able to make judgment calls using combination of knowledge of regulations, knowledge of technology, critical thinking, and interpretation of intent of the regulations
* Foster an environment of diversity and inclusion
* FDA regulated environment experience is required.
*It would be a plus if you also possess previous experience in:*
* >2 years of people management Experience
* Significant experience and understanding of quality assurance processes within the medical device industry with an analytical and organized approach.
* Knowledge of domestic and international quality systems and other standards such as FDA, QSR, ISO 13485, ISO 14971, World Health Organization or other applicable standards and regulations
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 [Register to View]
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.
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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 [Register to View]
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to request accommodation.
If you’ve ever wondered what’s within you, there’s no better time to find out.