DJO is looking of Quality Assurance Engineer 4 on Sun, 21 Apr 2013 05:42:22 GMT. DJO Global is a leading global developer, manufacturer and distributor of high-quality medical devices and services that provide solutions for musculoskeletal health, vascular health and pain management. We are currently seeking a Quality Assurance Engineer- Operations in Austin, Texas. We are located near 183/Burnet Road area. Summary: To execute and audit the Company's Quality System. This...
Quality Assurance Engineer 4
Location: Austin Texas
Description: DJO is looking of Quality Assurance Engineer 4 right now, this job will be placed in Texas. For complete informations about this job opportunity please give attention to these descriptions. DJO Global is a leading global developer, manufacturer and distributor of high-quality medical devices and services that provide solutions for musculoskeletal health, vascular health and pain management.
We are currently seeking a Quality Assurance Engineer- Operations in Austin, Texas. We are located near 183/Burnet Road area.
Summary: To execute and audit the Company's Quality System. This position reports directly to the Quality Assurance Director.
Essential Duties and Responsibilities:
- Assists process owners to write and issue procedures to assure compliance with the current QS regulations, CMDR and Mdd requirements; and to provide training to process owners related to QS requirements, as necessary. By the way of example and not exclusion, process may include Standard Operating Procedures (SOP's) manufacturing processes, inspection procedure and test procedures. Review and approve completed procedures to assure compliance with content and regulatory requirements.
- Participate in Material Review board (MRB) meetings; review and decide disposition of non-conforming materials.
- Trend product complaints, non! -conforming material reports and audit non-conformance for cor! rection action/preventative actions; report trend data to management.
- Participate in CAPA meetings to ensure adherence to requirements and closure of CAPAs.
- Access CAPAs to verify/validate the effectiveness.
- Assist process owners to determine root cause analysis and to create CAPA action plans.
- Review CAPA assignment responses for completeness and validity.
- Participate in new product status meetings - review project plans and give input to QA activities, milestones and procedures.
- Participate in design reviews to ensure adherence to design control requirements, material callouts and standards and procedures.
- Assure that product complaints are handled in accordance with requirements: report product complaints to Product Manager, assist in researching the circumstances of a complaint, facilitate CAPAs through the process, and report on product complaints at the CAPA meetings.
- Research details necessary to! initiate a recall, e.g. quantity and location of product involved, possible health hazards, other companies' recalls, audit findings, complaint trends or MDR/Vigilance corrective action. Report findings and recommendation to management.
- Direct activities related to the return and receipt of affected product from all locations.
- Conduct internal audits:
- Conduct interviews, summarize observations, conduct closing meeting with Department Supervisors, enter non-compliances into the CAPA system and trend software, and follow-up with process owners until CAPA is closed.
- Perform facility/supplier audits for compliance to requirements and to verify supplier capabilities and quality. Initiate CAPAs that result from the audit.
- Assist in Notified Body Audits, FDA inspections and other 3rd party audits.
- Performs other duties as assigned by Quality Assurance Director.
Requirements:
Education/Experience: - Bachelor's degree in Science or Engineering and 3 plus year! s of experience (CQA or RABQSA, CQE or CmfgE certification required)
. Requires certification to perform audits. Certification may be obtained through successful completion of an RAB auditor course, successful completion of CQA (Certified Quality Auditor) or on-the-job training by another qualified internal auditor.
- Requires experience necessary to demonstrate the capability to carry out specialized technical/trade/craft procedure. May require regular use of speaking skills to discuss/explain semi-complex information or writing skills to communicated standard matters or procedures.
- Requires experience in biomedical engineering standards and concepts. Required knowledge of FDA/GMP, CMDR, MDD and ISO 13485 quality standards.
- Requires basic knowledge of manufacturing processes (and associated tools, instruments and test equipment) to include inspection, machine shop technology, polish/grind and clean room technology.
- To perfor! m this job successfully, an individual should have knowledge of Microsoft Word, or equivalent word processing software; Excel, or equivalent spreadsheet software. Statistical analysis and data base searches.
You must state your salary requirements in order to be considered.
DJO Global is headquartered in San Diego, CA (Vista). The Company's 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. Its 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 the Company's medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment.
Our product lines include ri! gid and soft orthopedic bracing, hot and cold therapy, bone growth stim! ulators, vascular therapy systems and compression garments, 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®, Empi®, ProCare® and DJO® Surgical.
DJO is a portfolio company of the Blackstone Group.
EEO/AA-M/F/VET/HANDICAP
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If you were eligible to this job, please email us your resume, with salary requirements and a resume to DJO.
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This job starts available on: Sun, 21 Apr 2013 05:42:22 GMT
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