The Quality Assurance Engineer reports to the Site Quality Manager and will have primary responsibility for development and maintenance of production quality standards and documentation. This include, but is not limited to; defining quality requirements for new products and preparing/maintaining necessary documentation, monitor production quality performance to identify opportunities for improvement, review and maintenance of quality files, procedures, work instructions, in adherence to the Quality Management System, customer and regulatory compliance. This position will be responsible to assure 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).
Essential Duties and Responsibilities:
- Preparation, implementation, and maintenance of Master Quality Plan.
- Involvement in quality improvement facilitation by establishing methods of data collection, control charting, dimensional inspection, documentation, or other experimental design techniques.
- Involvement on the Master Validation Plan (IQ, OQ, PQ) regarding validation and verification Processes
- Responsible for continual improvement activities to enhance the quality system, such as 5S, Kaizen lean methods, etc.
- Develop training to build quality awareness.
- Interface with Engineering and Operations to ensure transfer to Production of new products are in accordance with approved data.
- Support the Quality Inspectors/Techs to ensure that products and processes comply with the relevant requirements of the quality management system.
- Conduct audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions.
- Analyze failure, corrective and preventive action to respond to customer complaints.
- Create and maintain company quality documentation, such as quality manuals, quality procedures, etc.
- Responsible for planning, organizing and managing the overall activities of receiving / outgoing quality functions.
- Continuously improving QA receiving inspection process and procedures.
- Ensure timely resolution of supplier failure, corrective actions and preventive actions.
- Assists in developing a good working relationship with manufacturing and support their gate-measurement issues.
- Assist in driving continuous improvements as necessary through the appropriate personnel.
- Manage Nonconformance System and the COPQ Initiatives.
- Manage the resolution of customer and internal quality concerns utilizing disciplined problem-solving techniques.
- Work on DOE projects with project Teams
- Facilitate and Manage Gage R&R, SPC and Capability requirements
- Participate on Launch and Current Production Engineering Changes
- Scrap Analysis Projects (Deep Dive), Data articulation
- Support Lean Initiates
- Daily review of Customer Scorecards
- Customer Visit and Support as required
- Supports the Incoming Inspection; help maintain files and backup supplies for inspection.
- Perform internal audits as per the audit schedule.
- Assist other Quality Department functions as needed. (Cross-training)
- Maintain reporting and disposal procedures for RMA scrap material.
- Insure a safe work environment is maintained, appropriate safety systems/processes are utilized, and insure compliance with all OSHA and other state/federal safety and environmental related rules and regulations.
- Provide growth and development opportunities for associate engagement and satisfaction.
- Maintain and comply with all other company and corporate systems and procedures as applicable for your area of responsibility.
- Assist in and support Notified Body Audits, FDA inspections and other 3rd party audits.
- Performs other duties as assigned by Management.
- 70% of time is spent in a resource capacity. 30% of responsibilities are in leadership activities.
To perform this job successfully, an individual must be able to perform essential duties satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required:
- A bachelor’s degree in Engineering or other technical discipline degree is required (or equivalent years’ experience).
- A minimum of 5 years of experience in quality engineering or related field with application and implementation of (GMP/QSR/ISO/MDD and Canadian Medical Device) regulations a plus, with focus on, process validations, product development supports
- Required knowledge of FDA/GMP, CMDR, MDD and ISO 13485 quality standards.
- ASQ certification with active local membership is preferred.
- Lean Six Sigma Green Belt or higher is also preferred.
- Experience with Quality related tools (D and P FMEA, QFD, SPC, Risk Analysis, DOE, and TQM)
- 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. Agile and Oracle experience highly desired.
- Experience in the Medical Device Industry and lean manufacturing is a plus.
- Must have statistical aptitude and understand concepts of geometric dimensioning and tolerance and knowledge of problem solving techniques.
- Personal computer skills are required, as well as excellent verbal and written communication skills.
Certifications, Skills, Competencies
- Expert 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.