Quality Assurance Specialist
Company: Disability Solutions
Location: Phoenix
Posted on: October 6, 2024
Job Description:
Linde Gas & Equipment Inc.Quality Assurance SpecialistLocation:
Phoenix, AZWhat we offer you!
- Competitive pay
- Comprehensive benefit plan (medical, dental, vision and
more)
- 401(k) Retirement Savings Plan
- Paid time off (vacation, holidays, PTO)
- Employee Discount Programs
- Career growth opportunitiesThe Quality Assurance Specialist
will be responsible for reviewing and ensuring all steps in the
manufacturing, testing, storage and distribution process for
medical products at the Bethlehem Facility and are performed in
accordance with FDA's applicable regulations and LINDE's standard
operating procedures. The Quality Assurance Specialist will handle
the quality oversight and auditing of production and incoming
inspection activities, review of change requests, and investigation
of non-conformances and out of specification reports. The Quality
Assurance Specialist will have the ability to work independently
and to provide consultative advice within specific areas of
expertise. Responsibilities
- --- Reviews all steps performed and ensures that the step in
the manufacturing process has taken place as defined in the Batch
Production Record.
- --- Reports findings of in-process errors and provides
follow-up to ensure adequate completion of corrective actions.
- --- Performs and coordinates quality investigations with
appropriate levels of corrective/preventive actions and closes in a
timely manner.
- --- Supports product quality complaint investigations,
assisting in data processing of Adverse Events and appropriate
reporting for U.S. and Canada complaints. Supports the
receipt/review of product complaint samples. Participates in the
investigation and resolution of non-conformances of all types.
- --- Quality review of System Preventative Maintenance
activities.
- --- Support initiatives in Continuous Quality Improvement.
- --- Provides training in GMP and quality principles to
personnel in all departments when assigned. Assists in maintenance
of training schedules and training records systems.
- --- Assists in the review and approval of Change Controls.
- --- Assists in internal and supplier audits and
establishing/updating supplier and component specifications and
testing as needed.
- --- Assists with tracking and trending of deviations and
complaints.
- --- Follows all safety rules/regulations and immediately
reports infractions and/or workplace injuries/accidents to proper
personnel.
- --- Ensures for product disposition, e.g., approvals for
release, distribution or rejection.
- --- Ensures labels are appropriately reviewed and approved for
use and meet all internal and external requirements
- --- Other duties as assignedWhat makes you great:
- --- Bachelor's/Associates Degree in a Science/ Engineering or
related technical field
- --- Background in quality medical products preferred
- --- Knowledge in the FDA's regulations for medical products 21
CFR part 210 and 211
- --- Strong communication skills & organizational agility
- --- Solid organizational skills
- --- Strong knowledge of Microsoft Office Applications and Lotus
Notes database skillsets
- --- Basic of HTML and JavaScript computer language
preferred
- --- ISO 9001 or ISO 13485 and or regulatory experienceLinde is
a leading global industrial gases and engineering company with 2023
sales of $33 billion. We live our mission of making our world more
productive every day by providing high-quality solutions,
technologies and services which are making our customers more
successful and helping to sustain and protect our planet. The
company serves a variety of end markets including chemicals &
refining, food & beverage, electronics, healthcare, manufacturing,
and primary metals. Linde's industrial gases are used in countless
applications, from life-saving oxygen for hospitals to high-purity
& specialty gases for electronics manufacturing, hydrogen for clean
fuels and much more. Linde also delivers state-of-the-art gas
processing solutions to support customer expansion, efficiency
improvements and emissions reductions. For more information about
the company, please visit our website at www.lindeus.com.All
qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, national origin, age,
disability, protected veteran status, pregnancy, sexual
orientation, gender identity or expression, or any other reason
prohibited by applicable law.
Keywords: Disability Solutions, Tempe , Quality Assurance Specialist, Other , Phoenix, Arizona
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