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 requirements.
- 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 audits.
- 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 improvements.
- 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 exclusion):
- Supplier Defective Parts Per Million (DPPM) and Yield trends
- Supplier caused Product complaints, non-conforming material reports and audit non-conformance for Supplier Correction Action Requests (SCARs);
- 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 procedures.
- 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 preferred)
- 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 procedures.
- 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 technology.
- 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 system regulations.
- 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® 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.