We are looking for an experienced Manager to ensure product
quality and reliability and the continual improvement of process
performance. This candidate will use sound Quality Engineering and
Lean-Six Sigma principles and tools to establish and ensure
compliance with regulations and policies and procedures in a
continual improvement environment. This position will be
responsible for reporting significant process metrics, quality
trends, and issues and managing any required root cause analysis
and implementation of effective correction actions.
?Responsible for the daily management Supplier Quality Engineering,
Supply Chain Technicians, and Quality Process Technicians.
?Responsible for the daily management of the Supervisors for Test
Engineering Technicians and Process Support Technician
?Coordinates and leads quality and process improvement activities,
including but not limited to, the management of Kaizen Events and
activities associated with Dock to Stock and Dock to Point of Use
?Prepares and manages labor, capital and expense budgets for the
?Establishes, monitors, and reports the statistical metrics for
supplier, production, and service quality, customer returns, and
the performance of supplier, production and service processes.
?Leads efforts in determining root cause analysis and implementing
effective corrective actions in response to quality and process
?Leads the Failure Review Board for root cause and corrective
action of trends associated with supplier failures, internal
failures, and external failures.
?Provides support in the development and validation of supplier,
production, and service processes and respective control
?Collaborates with Quality Systems and Standards Compliance on
Customer Complaints, leading activities associated with complaint
investigation and closure.
?Ensures that FDA and ISO standards are complied with in each area
of the department.
?Trains, supervises and reviews performance of department personnel
and maintains thorough documentation of all personnel issues that
require corrective action.
KNOWLEDGE, SKILLS, ABILITIES:
?Experience in Quality improvements and Process Improvements using
data and Lean-Six Sigma methods.
?Ability to be a team leader and hold employees accountable
?Strong written, verbal, analytical and diplomatic interpersonal
?Computer competency using Word, Excel and databases.
?Demonstrated ability to develop processes, define process
controls, and validate process and product performance.
?Knowledge of the U.S. FDA Quality System Regulation, 21 CFR Part
820 (QSR), and knowledge of international quality system standards,
ISO 13485, ISO 9001.
?ASQ certification desired.
EDUCATION AND EXPERIENCE:
?BA degree in an engineering discipline, Master?s Degree
?Minimum 3 years supervisory experience within a manufacturing
?Experience in analytical/problem solving using statistical based
?Certification in the principles and implementation of Lean
Manufacturing Strategies coupled with Six-Sigma experience strongly
We are an equal employment opportunity employer and will consider
all qualified candidates without regard to disability or protected