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Senior Quality Engineer - Foot & Ankle Medical Devices

Company: DJO
Location: Houston
Posted on: August 7, 2022

Job Description:

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.

As the Senior Quality Engineer you will assist the Director of Quality Assurance and Quality Control to ensure that all processes and end products meet or exceed the quality standards set forth by company, regulatory, and customer requirements supporting our Foot & Ankle Medical Devices. This includes but is not limited to performing document reviews and periodic audits; communicating deficiencies and quality improvement efforts to top management; conducting Root Cause Analyses to devise sustainable Corrective/Preventive Actions; ensuring timely response to regulatory audit findings; constructing quality plans; SOPs, and other quality reports; and training and mentoring staff on quality requirements to build and maintain a quality driven culture.

Location: This role can sit in any of the following locations:

Houston, Texas

Dallas, Texas

Austin, Texas

Essential Duties And Responsibilities

The following are the primary duties and responsibilities of this role. Other related duties may be assigned to meet the business need.

  • Developing and maintaining quality system policies and procedures to ensure regulatory compliance with FDA QSR, ISO 13485, and other regulations as needed
  • Owning, maintaining, and improving the CAPA, Supplier Corrective Action (SCAR), Nonconformance, Internal Audit, Supplier Audit and Complaint quality subsystems
  • Supporting development of a departmental strategic roadmap resulting in greater alignment between initiatives and strategy
  • Developing Continuous Improvement pipeline and portfolio of projects
  • Assuring compliance to FDA and ISO regulations and internal procedures
  • Preparing content and ensuring data accuracy associated with Management Review
  • Driving all quality improvement efforts to maintain Continuous Quality Improvement (CQI)
  • Participating in performance improvement activities, utilizing resources efficiently and effectively, and taking responsibility for own learning needs
  • Reviewing and approving product labeling, promotional material, advertisements, etc. to ensure compliance (according to US and international laws and regulations such as 21CFR820)
  • Developing and maintaining metrics that measures realization of business benefits and supporting performance assessment used to identify process improvements
  • Leading Continuous Improvement Initiatives and partnering with Project Leads through all phases of the projects, inclusive of Business Case Development, hosting Workshops, tracking projects through completion and challenging status quo
  • Leading Design Transfer efforts to ensure designs have been properly transferred to production facilities and manufactured product will meet or exceed quality goals and objectives
  • Assuring timely, effective, and within budget completion of assigned projects
  • Analyzing and recommending resources needed to meet project goals
  • Assisting in generating annual department budget and objectives
  • Training new department employees on department procedures, work instructions, forms, and any other aspect that will affect their responsibilities
  • Maintaining basic knowledge of competitive technologies, in addition to manufacturing and inspection developments in the field
  • Maintaining communications with customers and suppliers
  • Assisting and supporting other employees and teams as necessary
  • Other responsibilities assigned by supervisor including attending trade shows, surgery and other corporate functions associated with role as a Senior Quality Engineer
    Education And Experience
    • Bachelor's Degree ; MS Degree in an Engineering or Science discipline preferred
    • 5+ years business experience utilizing key Quality processes
    • Design control review and creation experience
    • Demonstrated experience in design transfer
    • Experience in DFMEA and risk assessments/analysis
    • Knowledge of FDA regulations (21CFR 820), ISO standards (ISO 13485), ANVISA, and other regulations as applicable
    • Demonstrated success delivering transformational expertise in design controls and design transfers with a cross-functional team
    • Affiliation with Quality professional organization(s) such as ASQ and associated certifications (CQM/OE, CQA, etc.) preferred
    • Certification in Lean/Six Sigma or working knowledge preferred
    • Organized, analytical approach to problem solving and comfortable negotiating across all levels/function
    • Strong leadership skills
    • Ability to audit processes and immediately identify areas of improvement in additional to areas of non-compliance to requirements as well as oversee action plans
    • Strong facilitation and coaching skills
    • Ability to translate customer needs into process improvements
    • Proficient in MS products (Word, Excel, Project, PowerPoint) and Minitab; SolidWorks preferred
    • Must be proficient in general computer programs such as Microsoft Office
    • Strong planning, organization, document review, and problem solving skills
    • Good understanding and execution of investigations and root cause analyses
    • Ability to articulate clearly; professional oral and written communication skills
    • Ability to use of "out of the box" thinking to devise corrective/preventive actions
    • Ability to prioritize and multi-task with little supervision
    • Previous work experience should demonstrate good interpersonal skills, strong process improvement skills, self- motivation, flexibility, detail-oriented work style, professional appearance and attitude, and ability to effectively communicate with customers/clients at all levels.
    • Must have legible handwriting
      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.

Keywords: DJO, Houston , Senior Quality Engineer - Foot & Ankle Medical Devices, Healthcare , Houston, Texas

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