Job Description

Cepheid is seeking a Quality Systems Specialist responsible for evaluating and improving the Quality Management System by employing best practices to ensure compliance to applicable Medical Device and IVD regulations/standards and Danaher Polices. The Quality Systems Specialist will participate in the Cepheid QMS internal audit program to verify compliance to internal Cepheid Quality Policies and Standard Operating Procedures, and external regulatory and customer requirements. The Quality Systems Specialist will support FDA, ISO, Danaher corporate, and other external audits.

Essential Job Responsibilities:

Functions as Lead Auditor to schedule, plan, perform, and document internal audits of Cepheids QMS.

Ensures that all internal audit findings are closed in a timely manner with effective corrective action by assisting observation owners on investigations, action plans, and/or verification plans.

Participate in MDSAP preparation, assessment, and audit management activities.

Participates in external audits (e.g. FDA, ISO, Danaher Corporate).

Provide continuous and rigorous assessment of the Quality Management System including Internal Audit and other processes as necessary to identify and implement improvements.

Be a subject matter expert on Internal Audit.

Build working relationships with cross functional teams including Development, Supply Chain, Program Management, Commercial Operations, Regulatory Affairs, etc. to ensure process solutions are compliant, efficient and adaptable to business units, sites and functions throughout the world.

Collaborates across the organization at all levels, across functional groups and geographic locations, including executive management. Implement tactical plans to meet Company and Corporate objectives, and supporting the development and implementation of policies to ensure compliance with applicable US Federal and local regulations

Maintains up-to-date knowledge and ensures compliance with local, state, and federal regulations and standards including compliance with all Food & Drug Administration (FDA) and European Union Medical Device Regulation (MDR) as well as other applicable global regulatory requirements.

Qualifications:

EDUCATION:

Bachelors degree with 2+ years of related work experience or Masters degree in field with 0-2 years of related experience.

TRAINING RESPONSIBILITIES: (REQUIRED)

Complete all assigned and required training satisfactorily and on time For people managers, ensure your associates attend and complete all required trainings satisfactorily and on time.

EXPERIENCE DESIRED:

Excellent verbal and written communication skills.

Lead Auditor Certification or CQA(B)

Possesses knowledge of domestic and international quality systems and other standards such as FDA QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971 and other applicable standards and regulations.

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 here.