Senior NPD/NPI Quality Assurance Engineer (Design Quality)

Job Description:

Are you looking for an exciting opportunity? Medical technology is a continuous growing industry. Take a step, bring your expertise and join our fast-growing Foot & Ankle division. This is a new division, and we are driving cutting-edge innovation. Our products cover a wide range of foot and ankle solutions to include the Arsenal Foot Plating System, DynaNail Hybrid, DynaNail TTC, and STAR Ankle.

Utilizing an advanced knowledge of engineering and problem-solving principles, this position is responsible for a variety of moderate to highly complex activities regarding the design, implementation, and maintenance of quality assurance protocols and methods to ensure external safety, quality and compliance with Company standards and government regulations. This position primarily supports New Product Development and serves as the QA representative on new product initiatives.

Duties may include but are not limited to: designing moderate to highly complex methods and procedures for inspecting, testing, and evaluating the precision and accuracy of production processes, equipment and finished products; performing moderate analysis of reports and production data to identify trends; initiating, developing and recommending updates or changes to quality standards and procedures; assuring compliance to internal or external specification and standards (i.e. GLP, GMP, ISO, Six Sigma); reviewing trends in device failures associated with customer complaints and nonconforming materials; participating or leading in corrective and preventive action investigations; working on moderate to highly complex special projects as assigned.

Responsibilities:

• Lead design and manufacturing reviews
• Generating DFMEAs/UFMEAs and lead in risk analysis discussions
• Reviewing and approving design and development documentation
• Serve as subject matter expert for design quality in ISO and FDA audits
• Authoring procedures and work instructions that define and govern the quality system
• Conduct internal audits of the quality system and other business functions
• Evaluating nonconforming material and dispositioning based on cross-functional engineering review
• Assuring compliance to internal and external specifications and standards (i.e. GMP, ISO, FDA, MDR)
• Reviewing trends in device failures associated with customer complaints and nonconforming material
• Leading and owning corrective and preventive actions
• Lead complex special design projects as assigned

Requirements:

• Bachelor's degree in Biomedical or Mechanical Engineering
• Minimum of 4 years of experience.
• Background in Medical Device, Aeronautics, Automotive or other highly regulated industry required
• Knowledge of technical writing quality and best practices.
• Basic knowledge of manufacturing processes: key focus into metrology, precision machining, grinding, product cleaning, and sterilization.
• Individual should have knowledge of Microsoft Office Suite of software or equivalent.

Desired Qualifications:

• Knowledge of the following software packages: Solidworks, Solidworks ePDM, Oracle R12, Agile PLM highly preferred
• Certification in CQE, Lean, or 6 Sigma
• Prior knowledge of and experience with 21CFR820 and ISO13485 quality standards.

Physical Demands

• Ability to tug, pull, or lift up to twenty (20) pounds
• Ability to sit or stand for extended periods of time

Work Environment

• General office environment. The office is clean, orderly, and properly lighted and ventilated. Noise levels are considered low to moderate.
• Direct exposure to manufacturing equipment and hazards. Noise levels are considered moderate to high.

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.