Surgical Supplier QA Engineer
Posted on: August 6, 2022
Summary: The Supplier Quality Engineer (SQE) position is
responsible to implement and perform Supplier Quality Engineering
activities at DJO Location(s) as assigned. The SQE will provide a
leadership quality role in the implementation of the Global
Supplier Quality Assurance Program. Utilizing an extensive
knowledge of engineering and problem-solving principles, this
position is responsible for a variety of the most complex
activities regarding the designing, implementation, and maintenance
of quality assurance protocols and methods to ensure external
safety, quality and compliance with the most complex Company
standards and government regulations. This position will be
responsible to identify and implement quality improvements with
strategic sourcing partners while ensuring compliance with FDA
regulations, ISO 13485 standards, as well as standards, regulations
and directives applicable to medical devices and Company strategies
(such as CMDR SOR/98-282, European Medical Device Directive,
Australia TGA). The position will report directly to the Senior
Manager of Global Supply Chain Quality.
Essential Duties And Responsibilities
- Write and issue procedures to assure compliance with the
current FDA QSR regulations, ISO 13485, CMDR and Medical Device
Directive requirements; and to provide training to process owners
related to Quality Management System 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
- Support New Supplier Approval process as Quality lead to ensure
adherence to local and global work instructions. Support
maintenance of the Approved Supplier List.
- Perform Supplier Evaluations by conducting remote performance
and desktop reviews.
- Facility, Product-Specific & Quality System audits for
compliance to requirements and to verify supplier capabilities and
quality. Initiate and manage CAPAs that result from the
- Support DJO Corrective and Preventive Action Process
- Investigate supplier caused product problems, driving root
cause identification and corrective actions.
- Manage Supplier Corrective Actions, communicating and
coordinating CAPA completion of suppliers.
- Support Internal CAPA Program as required, including by example
and not exclusion performing CAPA investigations and improvement
implementation, verifying implementation and effectiveness of
- Support Material Review board (MRB) meetings; review and decide
disposition of non-conforming supplied materials
- Support Nonconforming Material investigation and review,
maintain Agile NCMR data for supplier related NCMRs.
- Support the Global Supplier Review Board to review supplier
quality performance and trends. Develop and present supplier
metrics for review and track assignments and action items resulting
from SRB meetings. Metrics may include (by way of example and not
- Supplier Defective Parts Per Million (DPPM) and Yield
- Supplier caused Product complaints, non-conforming material
reports and audit non-conformance for Supplier Correction Action
- Supplier Corrective Actions
- Supplier Scorecard trends
- Support and facilitate Supplier Change notices
- Support Supplier Process validation activities.
- Support Certification of process and inspection methods to
enable reduced DJO inspection by leveraging certified supplier
inspection data and methods.
- Support New Product Development
- Participate in new product status meetings as required - review
project plans and give input to QA activities, milestones and
procedures related to Supply Chain plans.
- Support Design Transfer activities to ensure the qualification
of supplier manufactured parts and components
- Participate in design reviews to ensure adherence to design
control requirements, material callouts and standards and
- Conduct internal audits:
- Conduct interviews, summarize observations, conduct closing
meeting with Department Supervisors
- Enter non-compliances into the Agile system and trend software,
and follow-up with process owners until CAPA is closed.
- Assist in and support Notified Body Audits, FDA inspections and
other 3rd party audits.
- Performs other duties as assigned by Management
- Bachelor's degree in Science or Engineering and 3 plus years of
applicable experience (CQA or RABQSA, CQE or CmfgE certification
- Bilingual Spanish - English 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
- Requires experience in Medical Device engineering standards and
concepts. Required knowledge of FDA/GMP, CMDR, MDD, MDR, MDSAP 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
- To perform 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.
Skills And Technical Requirements
- Competent working knowledge of US and International quality
- Proven project management skills; able to complete technical
projects with minimal supervision. Strong interpersonal
communication and teamwork skill.
- Ability to understand and interpret drawings and data -
GD&T knowledge to interpret mechanical part drawings, assembly
drawings, block and flow diagrams, and BOMs.
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
For Additional Information On The Company, Please Visit
DJO is a growing subsidiary of diversified technology leader Colfax
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
Keywords: DJO, Austin , Surgical Supplier QA Engineer, Healthcare , Austin, Texas
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