Senior Director, Quality Systems
Company: Danaher Corporation
Location: Lodi
Posted on: February 25, 2021
|
|
Job Description:
Danaher Corporation Senior Director, Quality Systems in Lodi ,
California POSITION SUMMARY: The Senior Director, Quality Systems
will provide management and overall strategic direction and
operational coordination of activities for site Quality Operations
and Regulatory Compliance. The Senior Director, Quality Systems
will serve as the management representative for Cepheid - Lodi and
ensure compliance with FDA QSR, ISO 13485:2016, and other
applicable global regulatory requirements and alignment with
company objectives and Quality Standards. The Senior Director,
Quality Systems will report directly to the Vice President,
Manufacturing Quality and will supervise the Lodi, CA Quality
organization encompassing the Quality Control, Quality Engineering,
Quality Assurance and Quality Systems functions. ESSENTIAL JOB
RESPONSIBILITIES: Build, develop and manage a high performing
Quality team including Quality Control, Quality Engineering,
Quality Assurance and Quality Systems. Provide validation program
leadership for Cepheid facilities, manufacturing processes and
equipment. Maintain the Calibration Program Maintain the CAPA and
NCR systems Maintain Document Control Lead site Change Management
and Risk Management activities Directs and oversees the quality
planning processes; participates in strategic and tactical planning
processes. Collaborates across the organization at all levels,
across functional groups and geographic locations, including
executive management; manage matrices effectively. Communicates and
reports regularly to Quality management, users and staff on the
status of the quality system. Utilize Danaher Business System (DBS)
tools to drive compliance and effective processes Assure that there
are no significant interruptions to the business due to quality or
compliance issues Develops resourcing strategies, allocates
budgets, staff, tools and specialized support necessary for
efficient operations Lead employee development, communication and
training programs in connection with the company's strategic goals,
quality objectives, and operational systems. TRAINING
RESPONSIBILITIES: 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. MINIMUM REQUIREMENTS: Education and
Experience (in years): Bachelor's Degree in Engineering, Biology,
Biochemistry, or related field with 14 years of related experience
OR Master's degree in field with 12+ years of related work
experience 4 years of Supervisory or Department Lead experience in
managing both processes and resources Knowledge and skills: Medical
Device industry experience, preferably IVD Expert knowledge of US
FDA and ISO requirements Exceptionally strong team player with
excellent interpersonal and communication skills, and experience
working with end-users in a mentoring capacity Extremely
detail-oriented with strong organizational skills and high Quality
standards Develop strategic goals and objectives from knowledge
base and understanding of a customer's business. Manage changing
conditions, processes and approaches; lead organizations through
change effectively. Ability to adopt a systemic view of process
improvement and to advise process improvement teams to reach goals.
Track record of measurable, operational improvements to Quality
Systems related functions. DBS, LEAN or Six Sigma operational
excellence training or certification PREFERRED REQUIREMENTS: Seven
years of Department Leadership experience in managing both
processes and resources. Training and certificates in quality or
regulatory affairs (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean
Principles) Experience in Manufacturing Operations Experience with
molecular diagnostics Experience managing both Direct and Indirect
labor. 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. 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
(http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf)
.
Keywords: Danaher Corporation, Clifton , Senior Director, Quality Systems, Executive , Lodi, New Jersey
Click
here to apply!
|
Didn't find what you're looking for? Search again!
Other Executive JobsAssociate Director, Data Partnering, GDO and CD Description: Associate Director, Data Partnering, GDO and CD ul li Information Management li R1533077 li Full Time li 2020-12-02T00:00:00 0000 mail outlineGet future jobs matching this search or Job Description (more...) Company: Adecco Group Location: New Brunswick Posted on: 02/25/2021 Cost Accounting Manager Description: Job SummaryResponsible for gathering, analyzing and reporting all aspects relating to Plant Finance. The person will support activities of multiple locations in New Jersey.Area of ResponsibilityManage (more...) Company: ProStaff Solutions Location: New Brunswick Posted on: 02/25/2021 Regional Manager Description: Come Join Our Team Now Hiring Regional Manager Essex County, NJCompany OverviewIt is our belief that the delivery of hospice care can be taken to a new level of excellence by those who understand the (more...) Company: Grace Healthcare Services Location: West Orange Posted on: 02/25/2021 Associate Managing Director, Credit Risk and Forecasting Solutions Description: Associate Managing Director, Credit Risk and Forecasting Solutions ul li White Plains, NY, USA li Full-time li Department: Analytics Community li Is this an Analytics Req : No Company Description (more...) Company: Verisk Analytics, Inc. Location: White Plains Posted on: 02/25/2021 Senior Manager Business Solutions Description: Welcome to the HEINEKEN CAREERS website. A lot is Company: Heineken Location: White Plains Posted on: 02/25/2021 Associate Director, Digital Capability Management , PD Systems Description: Associate Director, Digital Capability Management , PD Systems New Brunswick - NJ - US At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.--In oncology, (more...) Company: Bristol-Myers Squibb Location: New Brunswick Posted on: 02/25/2021 Director of Human Resources Description: If you are a job seeker with a disability and require a reasonable accommodation to apply for one of our jobs, you will find the contact information to request the appropriate accommodation by visiting (more...) Company: Crescent Hotels & Resorts Location: White Plains Posted on: 02/25/2021 Regional Director of Resident Services Description: Regional Director of Resident Services - CT The Regional Director of Resident Services RDRS , along with the Executive Director and Resident Services Director RSD is responsible for overseeing the (more...) Company: Maplewood Senior Living Location: Westport Posted on: 02/25/2021 Director, Diversity & Inclusion Description: Director, Diversity InclusionReq : 18846 br Category: Leadership br Status: Full-Time br Shift: Day br Facility: RWJ New Brunswick br Location: Diversity Inclusion, One Robert Wood Johnson (more...) Company: RWJBarnabas Health Location: New Brunswick Posted on: 02/25/2021 Senior Vice President of Business Development Description: Our client is hiring for a permanent Senior Vice President of Business Development job in the White Plains, NY area. You will serve in a management and business development role that is responsible for (more...) Company: Location: White Plains Posted on: 02/25/2021 |