Quality Assurance Engineer II (Surgical)
Posted on: March 19, 2023
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).
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
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.
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
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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