Senior Quality Systems Specialist

Company: Danaher
Location: Sunnyvale
Posted on: June 12, 2021

Job Description:

POSITION SUMMARY:

Cepheid is seeking a Senior 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 Senior 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 Senior Quality Systems Specialist will support FDA, ISO, Danaher corporate, and other external audits. The Senior Systems Specialist will also participate in the CAPA program by working closely with CAPA owners and provide guidance on CAPA documentation.

ESSENTIAL JOB RESPONSIBILITIES:

• Functions as Lead Auditor to schedule, plan, perform, and document internal audits of Cepheid's 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).
• Working with CAPA owners to plan and document investigations, action implementation and effectiveness verification on time and according to procedure.
• Provide continuous and rigorous assessment of the Quality Management System including CAPA, Internal Audit, and other processes as necessary to identify and implement improvements.
• Be a subject matter expert on Internal Audit and CAPA practices.
• 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 Food & Drug Administration (FDA) and European Union In Vitro Diagnostic Regulation (IVDR) as well as other applicable global regulatory requirements.

MINIMUM REQUIREMENTS:

Education and Experience (in years):

• Bachelor's degree in field with 5 years of related experience or Master's degree in field with 3 years of related experience or Doctoral degree in field with 0-2 years of related work experience.

Knowledge and skills:

• Excellent verbal and written communication skills.
• Lead Auditor Certification or CQA(B)
• Possesses significant knowledge of domestic and international quality systems and other standards such as FDA QSR, IVDR, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971 and other applicable standards and regulations.

Physical Requirements/Abilities:

• Ability to work in an office environment

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.

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 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.

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 applyassistance@danaher.com to request accommodation.

If you've ever wondered what's within you, there's no better time to find out.

Keywords: Danaher, Sunnyvale , Senior Quality Systems Specialist, Other , Sunnyvale, California