Danaher Corporation Field Application Specialist, Quality and Compliance Manager in Phoenix, Arizona
Cepheid is currently looking for a Field Application Specialist, Quality and Compliance Manager – for a Remote position.
At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. As a member of our team, you’ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us, every moment of every day, to develop rapid groundbreaking solutions for the world’s most complex health challenges.
The FAS Quality and Compliance Manager provides technical support and management for Field Applications Specialist (FAS) team to support clinical and commercial manufacturing quality compliance requirements. This position provides guidance to FAS team regarding up-to-date regulatory guidelines from agencies such as CAP, CLIA, JCAHO, etc.. The right person will need to be self-motivated, process and detail oriented, and innovative with extensive experience in identifying, leading, and managing projects.
This role will perform continuous improvement initiatives to ensure high quality processes and provide an efficient framework towards continued success and reports to the FAS Director.
Essential job responsibilities:
Manages the quality compliance documentation for the FAS team including confirming all combined installation and training documents are accurate and in the correct locations.
Work directly with FAS Leadership to understand current state, future state, and the impact to our quality measurements and to confirm quality compliance.
Responsible for development of quality assurance standard work to align with current standard operating procedures (SOP) and for reviewing and editing FAS SOPs to align with global SOP when needed.
Maintains continuous alignment of QA operations with strategic business and quality objectives and possesses advanced skills in leadership, communication, influence, cross-cultural awareness, negotiation, and conflict resolution.
Responsible for providing mentorship to the FAS team on any regulatory changes or updates from such agencies as CAP, CLIA, JCAHO, etc.
Responsible for being the SME for document compliance for the FAS team during audits and participates in all audits related to installation and quality.
Education and Experience (in years):
Bachelor’s Degree in Medical Technology, Biochemistry, Molecular Biology, Microbiology or related field and a minimum of 9+ years of related Quality experience OR
Master’s degree in Biochemistry, Molecular Biology, Microbiology or related subject area and a minimum of 7+ years of related Quality experience.
3 + years Technical management experience.
Medical Device or Clinical Laboratory experience.
Knowledge and skills:
Knowledge of CFR 21 Part 820 (QSR), ISO 13485 is helpful
Experience in Field application activities including lab regulatory requirements to include test method validation.
Experience representing their department during quality system audits.
Ability to train others in Good Documentation Practices
Clear understanding and ability to create and perform document changes for batch records, processes, procedures, and policies.
The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.
As part of the Danaher family of companies, our work at Cepheid is supported by a global science and technology innovator. In addition to Danaher’s unrivaled leadership training and professional development programs, this relationship also provides expanded career opportunities across industries and brands. Together, we are united by a shared purpose: Helping Realize Life’s Potential.
Individuals who need a reasonable accommodation because of a disability for any part of the employment process should call 202-419-7762 or e-mail email@example.com to request accommodation.
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 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 202.419.7762 or firstname.lastname@example.org to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.
Operating Company: Cepheid