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ASQ
Members ads: Principle Quality Engineer
At Cardinal Health, we are developing the innovative products and services
that make healthcare safer and more productive. Join a growing, global company
genuinely committed to making a difference for our customers and communities.
The Principle Quality Engineer is
A) Responsible for coordinating Quality Engineering process improvement efforts regarding customer complaints. B) Experienced with FDA regulations. C) Responsible for overseeing failure analysis, documenting failure analysis and recommending corrective action for instrument complaint, service, production and receiving inspections issues. D) Responsible for supporting Development of new products/Operations Engineering and manufacturing to resolve technical issues and implement corrective and preventive action for Cardinal Health products. E) Responsible for reviewing Non-Conformance Materials Review to verify discrepancy and adequacy of response to corrective action request. F) Reviews and approves test and Verification and Validation documents and Change Orders for new designs and design changes. G) Reviews and Approves Change Order to correct drawings and specifications and Quality System Procedures. H) Performs supplier audit, evaluation, and assessment, I) Experience with product Design History File maintenance and adequacy of documentation. J) Performs Hazard Analysis, Risk analysis, Failure Mode Effect Analysis, Process Failure Mode Effect Analysis. K) May perform Quality Manager's responsibilities in his/her absence.
Requirements:
1.Bachelor's degree in technical field and 8 to 12 years experience is required and; equivalent combination of education and experience. 2.Direct experience with Medical Devices and disposables, in a regulatory environment (i.e. GMP, ISO9001, EN46001, etc.) preferred. 3.Must be able to apply GMP principles to the complaint handling process. 4.ASQC Certified Quality Engineer preferred.
Benefits:
Cardinal Health offers a competitive compensation and benefits package including 401K plan and an employee stock purchase plan. Pre-employment drug and background screening are required for all positions.
More information about the company may be found at www.cardinal.com
We are an Equal Opportunity Employer M/F/D/V
Diversity Works Here.
If interested please contact Melinda at Melinda.bourg@cardinal.com
or call 858-458-6184
Quality
Engineer
Expires July 31st 2007 Position Description Summary: Leads
the company’s process improvement efforts by evaluating work processes to
determine strategies and programs which provide greater productivity,
efficiency and improvement through quality tools and lean manufacturing
techniques. Interacts with functional groups
to promote and support the company’s management systems procedures and
ensure the systems conform to international standards adopted by Jazz,
including legal/statutory requirements, the needs of customers and interested
parties. This position works closely with all functional areas to
resolve technical and non-technical issues in addition to managing management
systems databases that support the company’s business strategies.
Essential
Duties and Responsibilities: Ø
Work across all
functional areas of the company to create teams to execute process improvement
and change management. Ø
Identify gaps,
redundancies, interdependencies, and opportunities for improvement. Coordinate
processes to improve operational stability, efficiency, and profitability and
maximize business results. Analyze processes and assist in continual
improvement. Reviews and corrects accuracy of the
process flow charts. Ø
Gather
information to evaluate current work processes in order to determine the flow
of work, time requirements, cost and duration. Ensure departments work
together to accomplish business goals and objectives. Make operational
recommendations and transform them into successful training programs and
realizable, positive results on the Fab floor. Ø
Perform
root cause analysis, process mapping, and cost time management. Reports
to top management on the performance of Jams, quality metrics and the need for
improvement. Ø
Schedule
and facilitate meetings to review the SPC status of critical charts, summarize
out-of-control conditions, and follow-up with area engineers to address
issues. Collaborate with different areas and identify methods of analyzing and
monitoring SPC conditions, as well as process enhancement projects. Ø
Apply
lean manufacturing problem solving and productivity techniques to evaluate the
improvement of recommended strategies and programs. Perform Risk Analysis (FMEA)
and enhance Fab process controls by
implementing good statistical process control (SPC) practices Ø
Instruct
others in continuous process improvements, including the use of various
problem solving and productivity techniques. Train and coach Department
Leaders on Process Improvement (including 6S) and Lean Manufacturing tools and
techniques to build cohesiveness and improve the overall results of the
respective teams’ tasks. Ø
Develop,
administrate and maintain data queries/ reporting programs and quality
management system software that monitors: training records, document control,
corrective/preventive actions and internal audits. Maintain
quality databases - Resolve conflicts, interact with consultants to get
solutions, maintain
information catalog and provide feedback to Quality Group Leader Ø
Coach
facilitators and supervisors to identify
areas of improvement. Review statistics, projects and opportunities for
improvement. Provide guidance and ongoing training to facilitators in order to
drive process improvement, enabling all workers to be included and involved in
ongoing changes and improvements. Ø
Monitor
and support process improvement activities across multiple projects working
actively with managers and senior management to resolve non-compliance issues
and respond to business development and process improvement needs. Manages
effective use of Corrective & Preventive Action Systems (PAR/CAR). Ø
Analyze
work force utilization, facility layout, and operational data such as
fulfillment costs, process flow charts, and workforce schedules to determine
efficient utilization of labor. Evaluate methods for improving worker
efficiency and reducing waste of materials and utilities such as reorganizing
work flow, relocating work stations, equipment, etc. Ø
Train,
mentor and advice internal auditors: ISO 9001, 14001, 27001 and soon OHSAS
18001. Working
Environment: Assignment Complexity – ð
Interfaces directly with
internal customers to ensure compliance to international standards. ð
Works on assignments that
are complex in nature where considerable judgment is required. ð
Coordinates complex
project management assignments to support the company. ð
Provides input on
decisions that have an impact on the current and future business strategies Working
Relationships – ð
Interfaces with internal
customers and all department functions and personnel within Jazz. Experience/Proven
Skills: ·
3+ years
experience that has provided a strong understanding of the manufacturing
environment ·
Demonstrated analytical skills. Demonstrated
highly developed communication skills and ability to build rapport with
customers and peers ·
Effective verbal and communication skills; Ability
to articulate benefits and importance of processes ·
Project management experience with proven
team leadership skills and a thorough understanding of process mapping ·
Ability
to write reports, procedures and effectively present information and respond
to questions from groups of operators,
managers and customers ·
Ability
to define problems, collect data, establish facts, and draw valid conclusions.
Ability to analyze and interpret an extensive variety of data and statistical
techniques ·
Computer experience is
necessary to assist in the tracking and reporting of key departmental metrics.
The successful candidate will use their knowledge/expertise learned on the job
to make suggestions for quality/productivity improvements and implement
changes where possible. ·
Experience
with, Six Sigma/Lean manufacturing practices and ISO certification process. ·
Knowledge
of statistical process control, SPC
software and Quality System Databases ·
Ability
to influence peers, managers, executives and other teams without direct
authority. ·
Ability
to work effectively in teams and manage intense detail for the ongoing
improvements, keeping the ·
Experience in business
improvement with a proven track record in delivering sustainable value. Education/Licenses/Certifications: · Bachelor’s degree from four-year College or University or equivalent education and experience .
Contact
Info: Marcelo
Espinosa-Trevino Jazz
Semiconductor; |
This
AD expires on December 31st unless renewed by the employer SOFTWARE QUALITY ENGINEERING MANAGER
– Boulder, CO Position Summary: Oversee
and manage Software Quality Assurance Engineers ensuring that software
used in the development, manufacturing, and as part of medical devices
is developed according to good design practices as set forth by
regulatory authorities (e.g. FDA/TUV).
Minimum
Requirements: BS degree in
Electrical Engineering, Computer Science, or Computer Engineering 6+ years exp in
software test or software quality engineering with embedded software
as part of a medical device Experience in a
management role Working knowledge
of and auditing experience to the FDA Quality System Regulation, ISO
13485, & Medical Device Directive Skilled in product
risk assessment (ISO 14971), requirements management and tracing,
defect tracking, configuration management techniques, and how they are
applied in the software development lifecycle Understanding of
current Software Quality techniques, software industry standards (e.g.
ISO, IEEE, CMMI), and FDA Quality System Regulations and their impact
on internal procedures, software quality, safety and efficacy of
products Working knowledge
of C, C++ CSQE Certification SR.
SOFTWARE QUALITY ENGINEER – 1 position Boulder, CO & 1 position
Carlsbad, CA Position
Summary: Ensuring
that software used in the development, manufacturing and as part of
medical devices is developed according to good design practices and
follows the corresponding requirements set forth by local procedures,
regulatory authorities and notified bodies.
Provide leadership, oversight and training to division
manufacturing plants for computerized system validation.
Minimum
Requirements: BS in
Electrical Engineering, Computer Science, or Computer Engineering 5+
years in software quality engineering role dealing with embedded
software that is part of a medical device. Working
knowledge of the FDA Quality System Regulation, ISO 13485, and the
Medical Device Directive Skilled
in product risk assessment (ISO 14971), requirements management and
tracing, defect tracking, configuration management techniques, and how
they are applied in the software development lifecycle Understand
current Software Quality techniques, software industry standards (e.g.
ISO, IEEE, CMMI), and FDA Quality System Regulations and their impact
on internal procedures, software quality, safety and efficacy of
products Working
knowledge of C, C++, and LabVIEW REGULATORY
AFFAIRS SPECIALIST – Boulder, CO Position
Summary: Ensures
compliance to FDA and other applicable regulations.
Prepares, analyzes, and submits dossiers to various governing
agencies in supporting business growths.
Supports applicable regulations including ISO, local, state,
and/or federal requirements. Minimum
Requirements: 5-8
years of RA experience B.S.
or B.A. degree required. Must
have knowledge of U.S. and/or European/International regulations and
standards Experience
in preparing regulatory submissions Experience
interacting with FDA and/or other regulatory agencies COMPLIANCE
OFFICER – Boulder, CO Position
Summary: Develops,
establishes and maintains quality assurance and regulatory programs,
policies, processes, procedures and controls to ensure that the
performance and quality of products conform to established standards
and agency guidelines. Minimum
Requirements: BS/BA
degree or equivalent experience with 3-7 years medical device. •2
years auditing experience; hands on experience managing and/or
supporting FDA and Notified Body inspection/audits. •Comprehensive
knowledge of FDA Quality System Regulation, ISO, Medical Device
Directive, Canadian Medical Device Regulation, and other international
requirements. •Knowledge
of all Quality System elements, including Complaint Handling, CAPA,
Design Control, Validation Review •ASQ
Certified Quality Auditor and Lead Auditor training are highly
desired. For more
information about these and other opportunities go to: www.covidien.com/careers.
Pull up jobs for Boulder, CO.
Respiratory jobs are listed under Nellcor/Puritan/Bennett. Recruiter Contact
Information: Deborah.Cason@covidien.com |
