Quality Assurance Engineer II (Surgical)
Company: Enovis
Location: Austin
Posted on: March 19, 2023
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Job Description:
Job Description:
Summary:
Utilizing a comprehensive knowledge of engineering and
problem-solving principles, this position is responsible for a
variety of complex activities regarding the design, implementation,
and maintenance of quality assurance procedures and work
instructions to ensure external safety, quality, and compliance
with complex Company standards and government regulations.
This position primarily supports Product Development, serves as the
QA representative on design initiatives, and supports Quality
System activities (i.e., CAPAs, Complaints, Audits,
Nonconformances, DHR reviews).
Responsibilities:
Participating in design reviews
Generating DFMEAs/UFMEAs and participating in risk analysis
discussions
Reviewing and approving design and development documentation
Serve as subject matter expert for design quality and quality
assurance in ISO and FDA audits
Authoring procedures and work instructions that define and govern
the quality system
Initiating, developing, and recommending updates or changes to
quality standards and procedures.
Conduct internal audits of the quality system and other business
functions
Assuring compliance to internal and external specifications and
standards (i.e., GMP, ISO, FDA, MDD)
Evaluating nonconforming material and dispositioning based on
cross-functional review
Evaluating and investigating customer complaint investigations
Reviewing trends in device failures associated with customer
complaints and nonconforming material
Leading and owning corrective and preventive actions
Assisting with document control, change control, calibration,
metrics, supplier management, DHR reviews, and training aspects of
the QMS
Supporting validation planning and testing on computer-assisted
surgery systems
Working on complex special projects as assigned
Qualifications:
Bachelor's in Biomedical or Engineering or Science and 2+ years of
experience (preferred). Equivalent experience may be considered in
lieu of a degree for exceptional candidates
Background in Medical Device or other highly regulated industry
required; preferred knowledge of ISO 13485 quality standards.
Knowledge of technical writing quality and best practices.
Required basic knowledge of design and manufacturing processes:
preferably with electro-mechanical assemblies and components
Individual should have knowledge of Microsoft Office Suite of
software or equivalent.
Preferred knowledge of electronic QMS software.
Essential Requirements:
Must possess the knowledge, skills and abilities or be able to
explain and demonstrate that they can perform the essential
functions of the job, with or without reasonable accommodations,
using some other combination of skills and abilities.
Accurate and professional communication
Accurate and professional written communication (email, text and
formal letter)
Position is office based (Austin, TX)
Must be able to lift 50 lbs.
Must be able to bend, twist and lift overhead.
Must possess professional ethics and demeanor
Must demonstrate excellent customer service.
Computer skills (Excel, Word, Power Point).
Must be able to communicate in English clearly and fluently, in
both written and verbal skills
#ENOV1
ABOUT DJO GLOBAL
DJO Global is a leading global developer, manufacturer and
distributor of high-quality medical devices that provide solutions
for musculoskeletal health, vascular health and pain management.
Our products address the continuum of patient care from injury
prevention to rehabilitation after surgery, injury or from
degenerative disease, enabling people to regain or maintain their
natural motion. Our products are used by orthopedic specialists,
spine surgeons, primary care physicians, pain management
specialists, physical therapists, podiatrists, chiropractors,
athletic trainers and other healthcare professionals. In addition,
many of our medical devices and related accessories are used by
athletes and patients for injury prevention and at-home physical
therapy treatment. Product lines include rigid and soft orthopedic
bracing, hot and cold therapy, bone growth stimulators, vascular
therapy systems and compression garments, therapeutic shoes and
inserts, electrical stimulators used for pain management and
physical therapy products. Our surgical division offers a
comprehensive suite of reconstructive joint products for the hip,
knee and shoulder. Our products are marketed under a portfolio of
brands including Aircast -, Chattanooga, CMF---, Compex -, DonJoy
-, ProCare -, Exos---, Dr. Comfort -, DonJoy Performance - and DJO
- Surgical.
For additional information on the Company, please visit
www.DJOglobal.com.
DJO is a growing subsidiary of diversified technology leader Colfax
Corporation
EOE AA M/F/VET/Disability
All qualified applicants will receive consideration for employment
and will not be discriminated against on the basis of race,
religion, color, national origin, sex, protected veteran status,
disability, or any other basis protected by federal, state or local
laws.%48671976% %%techsoftware%%
Keywords: Enovis, Austin , Quality Assurance Engineer II (Surgical), Healthcare , Austin, Texas
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