Senior Quality Engineer
Company: BD, Becton and Dickinson
Location: Louisville
Posted on: January 14, 2021
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Job Description:
Job Description SummaryJob DescriptionThe Sr. Quality engineer
is responsible for ensuring TTM products are developed and released
meeting customer expectation, regulatory requirements, appropriate
voluntary standards, and BD policies and procedures. This position
will work as a member of a TTM cross-functional project team
engaged in ongoing Product Life Cycle technical support. Will serve
as a quality representative on project core teams and will work
closely with R&D, Operations, Regulatory Affairs, Marketing and
Distribution. This position requires a self-directed individual
able to handle multiple projects and tasks utilizing a high level
of written and oral communication skills. In addition the incumbent
may be expected to initiate quality initiative projects, become
thoroughly knowledgeable with all aspects of Sustaining Engineering
and/or New Product Development projects, and assume personal
responsibility for the successful completion of all tasks within
the realm of Quality Engineering responsibilities.ESSENTIAL DUTIES
AND RESPONSIBILITIES Represents the Corporation, Division and
Quality Department in a professional manner.Participates on Project
Team as Quality Representative. Ensures that principals of Design
Control are applied to Product and Process Changes and New Product
Development.Provides Quality Assurance leadership for Project Teams
or Quality Department.Creates, reviews and approves Quality System
Documents (CAPA, Audits)Creates, reviews and approves Product
Documents, such as Design History FilesCreates, reviews, and
approves Protocols, Process and Product Validations, Stability
Protocols, Software Validation documents and Test Method
ValidationsCreates reviews and approves Risk Management Files
documents such as: Risk Management Report, Hazard Analysis, Risk
Benefit Analysis and FMEA---sProvides supervision to technicians
and engineersAnalyzes process and product non-conformance and
implement comprehensive corrective and preventive action
plans.Performs Internal or Supplier Quality System Audits.Ensures
compliance to Department and Division procedures.Participates and
has membership in trade and/or professional organizations to ensure
that state-of-the-art industry standards are communicated into the
division in an efficient, timely, and accurate manner.Drives
Reliability planning and Quality Planning for New Product
Development.Perform failure investigations and implement
comprehensive corrective and preventive action plans using
methodologies as Six Sigma/Lean Six SigmaInterfaces with
manufacturing facility or other Division Facilities.Other duties as
assigned.QUALIFICATIONSAbility to perform engineering work of a
broad nature with little or no direction from Quality Management.
Generally, receives guidance on novel or controversial
problems.Extensive knowledge of medical device regulation, industry
or international standard, including management responsibility.
Ability to understand Division and Plant Quality Systems and be
able to implement systemic changes to enhance product quality and
improve business efficiency. Ability to interface with regulatory
bodies to present technical information.Comprehensive knowledge of
quality systems and relationship to business.Has experience in
writing process, software, and equipment protocols/validations and
has fundamental knowledge of validation principles.Understands
basic applied statistics, statistical sampling plans, and
statistical process control and advanced statistical methodologies
such as DOE and Taguchi.Ability to participate and provide
leadership on teams and maintain positive work environment with
those teams. Understands team functions, leadership techniques and
project management methodologies. Broad knowledge of manufacturing
processes. Excellent communication skills (verbal, written, and
presentation). Understands how to present information dependent
upon the level of the audience.Understands Fundamentals of
Engineering Principles.Ability to effectively manage time and
handle multiple task assignments.Ability to translate quality
requirements into product specifications and interpret Regulations,
Corporate, Division and Department Procedures.EDUCATION and/or
EXPERIENCEB.S. in Engineering, Engineering Technology, Science or
related field a minimum. Minimum 7 years of experience with FDA
regulated industry including 3 years on product development
programs.1 - 2 years experience with electromechanical
devicesAmerican Society of Quality (ASQ) certification (CQE, CQA,
CQM, etc.), preferredAt BD, we are strongly committed to investing
in our associates---their well-being and development, and in
providing rewards and recognition opportunities that promote a
performance-based culture. We demonstrate this commitment by
offering a valuable, competitive package of compensation and
benefits programs which you can learn more about on our Careers
Site under ---Our Commitment to You---. The anticipated
compensation range for this position is $81,300.00 - $134,100.00
USD Annualand the compensation offered will depend on the
candidate---s qualifications.BD follows the Pay Transparency and
non-discrimination provisions described by the Colorado Department
of Labor and Employment (CDLE).Becton, Dickinson and Company is an
Equal Opportunity/Affirmative Action Employer. We do not unlawfully
discriminate on the basis of race, color, religion, age, sex,
creed, national origin, ancestry, citizenship status, marital or
domestic or civil union status, familial status, affectional or
sexual orientation, gender identity or expression, genetics,
disability, military eligibility or veteran status, or any other
protected status.LI-PROPrimary Work LocationUSA CO -
LouisvilleAdditional LocationsWork ShiftFull time
Keywords: BD, Becton and Dickinson, Denver , Senior Quality Engineer, Engineering , Louisville, Colorado
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