Job Description

Position Summary

The Manager, Quality Control provides technical support and management for Quality Control to support clinical and commercial manufacturing requirements and Cepheids control material program. You will provide guidance to lab personnel for testing of raw materials, control materials and assays for product qualification and release as well as select, develop and evaluate personnel to ensure the efficient operation of the Quality Control function. In this role, you will also perform activities in concordance with 21CFR Part 820 Quality System Regulations and all Cepheid and Danaher policies.

Essential Job Responsibilities:

* Responsible for the hiring, training and development of Quality Control personnel.
* Develop and maintain Quality Control metrics to assess department and product performance.
* Maintains continuous alignment of Quality Control operations with strategic business and quality objectives; possesses advanced skills in leadership, communication, influence, cross-cultural awareness, negotiation and conflict resolution.
* Works cross-functionally and consults frequently with Manufacturing, Supply Chain, Engineering, Research and Development, Quality Assurance, and Product Transfer and other functional groups.
* Routinely communicates project goals, status, requirements, and deliverables to Quality Management
* Identify and drive countermeasures in instances when metrics are not meeting goals
* Effectively communicates and maintains visual tools for department performance
* Effectively employs Danaher Business System (DBS) tools and concepts to maximize efficiency and quality Communication focal point for Quality Control to Quality Management
* Establish and monitor use of tools for project tracking and management
* Works effectively with all team members, stakeholders and supervisors

Qualifications:

* 3+ years experience leading Quality Control personnel and laboratory operations to support testing and qualification of raw materials, commercial product, and the manufacture of assay control materials.
* Ability to develop and maintain the Quality Control system to track control materials, assure material stability and troubleshoot material issues as necessary.
* 3 + years experience with a proven track record leading technical laboratory personnel
* Demonstrated leadership skills and the ability to influence others in cross functional environment

Education and Experience Requirements:

* Bachelors Degree in Biochemistry, Molecular Biology, Microbiology or related discipline and a minimum of 9 years of related Quality experience OR
* Masters degree in Biochemistry, Molecular Biology, Microbiology or related discipline and a minimum of 7 years related Quality experience.
* Medical Device or Clinical Laboratory experience.

Preferred Requirements:

* Experience in the medical device industry, knowledge of CFR 21 Part 820 (QSR), ISO 13485
* Experience with Cepheid assays and instruments.

Knowledge and skills:

* Experience in the application of production and process controls including process and test method validation.
* Experience representing their department during quality system audits.
* Demonstrated superior communication skills, both oral and written.
* Fast learner, with the ability to quickly become adept at using the Danaher Business System tool set.
* Readily accepts responsibility and accountability for department performance and key decisions.

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.