Sr Quality Engineer, Paragon
Company: The Cooper Companies
Location: gilbert
Posted on: May 3, 2021
Job Description:
DescriptionCooperVision, a division of CooperCompanies
(NYSE:COO), is one of the world's leading manufacturers of soft
contact lenses. The Company produces a full array of daily
disposable, two-week and monthly contact lenses, all featuring
advanced materials and optics. CooperVision has a strong heritage
of solving the toughest vision challenges such as astigmatism,
presbyopia and childhood myopia; and offers the most complete
collection of spherical, toric and multifocal products available.
Through a combination of innovative products and focused
practitioner support, the company brings a refreshing perspective
to the marketplace, creating real advantages for customers and
wearers. For more information, visit www.coopervision.com Who We
AreParagon Vision Sciences, Inc., a Cooper Vision specialty eye
care company, is a world leading manufacturer of specialty contact
lenses and oxygen permeable contact lens materials. Our CRT lens (a
class three medical device) is considered the lens of choice by
many eye care professionals around the world. Paragon's office is
located in Gilbert, Arizona. Why Work With UsWe are certified as a
Great Place to Work! Our environment recognizes each employee as a
vital member of the team. Integrity and respect are fundamental to
our working relationships. We are friendly, inventive, and
dedicated. We don't quit until the job is done right! Our lenses
don't just change vision, they change lives. Join a team that is
passionate about improving other's visual health and quality of
life. Job Summary:Uses Quality Engineering principles - Problem
Solving and Root Cause Analysis tools and techniques to develop and
optimize systems and processes so that they are aligned with the
overall Company strategy. Oversees process to assure all processes
comply with company specifications to include QSR and ISO
requirements. Reviews, develops, and maintains all associated
documentation. Leads and assists in process and product improvement
projects. Provides technical input and assistance while adhering to
regulatory requirements. Essential Functions &
Accountabilities:Support and review Design Control activities for
new products or process development, including design and
development planning, design reviews, design input/output, design
verification/validation, design history files, design transfer,
risk management, etc. Coordinate the development of product
DHF.Utilize risk-based approach to assess and control design and
manufacturing changes. Provide quality engineering support in
design and development of medical device products to ensure that
quality requirements are translated into product and process
functional specifications. Provides technical leadership to support
product transfers and launches in compliance with Design Control
and other applicable procedures.Develop and/or review of
product/process development documentation, software/computer system
validation, and process validation documentation.Support the
development of the inspection methodology and acceptance criteria
for sampling plans, including the incoming, in-process, final, and
validation sampling plans as part of the design development
process.Lead statistical analysis for sampling plan rationale and
analysis, including but not limited to, DOEs, Paretos, ANOVA, and
SPC applications.Perform internal and external Audits to maintain
Quality System Regulation requirements.Support company goals and
objectives, policies, and procedures in compliance with quality
manual and quality system processes such as CAPA system, change
control, etc.Creates a culture of quality awareness, teamwork, and
cooperation with all groups within the facility.Works closely with
Regulatory Affairs, Research and Development, Manufacturing,
Clinical and other functional groups, to ensure compliance to
applicable standards (external and internal) such as ISO 13485, ISO
14971, and FDA QSR/GMP.Examines work for thoroughness, exactness,
neatness and conformance to policies and procedures.Investigates
instances of nonconforming material and facilitates the
determination of root cause and corrective action/preventive
action. Leads teams responsible for the improvement
activitiesParticipates in supplier approval and evaluation and
leads supplier improvement efforts.Coordinates calibration and
training requirements for the department. Other duties as assigned.
CooperVision's management team is committed to the development of
and implementation of the quality management system and maintaining
its effectiveness by communicating to the organization the
importance of meeting customer as well as statutory and regulatory
requirements. Travel: Travel will be limited but may include both
domestic and international destinations QualificationsKnowledge,
Skills and Abilities: Must have experience with Internal Auditing
in a Medical Device field. Audit Training certifications
preferred.Technically sound in quality systems and be abreast of
developments in the Quality Assurance field. Including practical
application of ISO 13485 and FDA Quality System Regulation 21 CFR
part 820.Must possess the ability to read, analyze, and interpret
general business periodicals, professional journals, technical
procedures, or government regulations. Able to write reports,
business correspondence, and procedure manuals. Possess the ability
to effectively present information and respond to questions from
groups of senior managers and the public.To be successful in this
role the individual must be able to work with mathematical
concepts. Ability to apply concepts such as fractions, percentages,
ratios, and proportions to practical situations. Must possess the
ability to interpret a variety of instructions furnished in
written, oral or diagram format.Applied technical knowledge of
Qualitative and Quantitative data analysis, and statistical tools.
Six Sigma GB or CQE preferred.GCP or GMP experience is a
plus.Self-starter and able to work both independently and as a
leader of an integrated, interdisciplinary team in carrying out
assigned responsibilities.Excellent interpersonal and written
communication skills to communicate effectively at all levels
within Quality as well as cross functionally with departments such
as R, Regulatory, Manufacturing, and Marketing.Proficient in
Microsoft Office tools. Work Environment:Office working
environmentUse of computer systemsThe employee may be
intermittently exposed to moderate noise levels.Must be able to
travel periodically to perform external Audits Experience:Minimum
of 8 years' experience as a Quality Engineer, or similar role in
the medical device field. Education:Bachelor in an Engineering or
Science discipline or equivalent combination of education and
experience. #LI-SD-1
Keywords: The Cooper Companies, Gilbert , Sr Quality Engineer, Paragon, Other , gilbert, Arizona
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