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Quality Assurance Specialist - Document Control

Company: Lima Corporate
Location: Arlington
Posted on: August 7, 2022

Job Description:

Lima USA is looking for a skilled and passionate Quality Assurance Engineer to join our family.
The role, reporting to the Sr. Quality Assurance Specialist will lead and support quality related activities within the business: incoming, in-process and final inspection, product/processes conformity audits, quality system audits and international standard compliance. Identify and implement procedures to continuously improve the quality system.
Specific Job Responsibilities:

  • Support the management of Lima-USA Quality System
  • Ensure that the facility's Quality System is established and maintained in compliance with applicable local ordinances, State statues, and Federal regulations, and other laws, including Ti-tle 21 CFR 820 Regulations
  • Maintain compliance with FDA 21 CFR Part 820 Quality System Regulation
  • Manage the measuring equipment (selection, identification, calibration and maintenance)
  • Support internal and supplier related quality issues
  • Understand and communicate regulations and guidelines and assess the implications for strategic business decisions
  • Implement, maintain and enhance programs and procedures which guarantee the continuous improvement of organizational processes
  • Plan Internal Audits, monitoring their performance and the management of any non-conformity
  • Interface with compliance / regulatory agencies (e.g. FDA)
  • Interface with all applicable vendors, suppliers, customers, and contractors, and consultants
  • Manage complaints, Non-conformities and CAPAs
  • Carry out periodic reviews of the Quality System, collecting and analyzing data related to processes performance
  • Ensure correct and efficient execution of the receiving inspection, in-process inspection and final release
  • Plan, develop, and document the quality systems procedures for the facility
  • Ensure that all necessary documentation for release of product is completed and all specifications have been met prior to release of any component
  • Manage the sites training program to verify that plant personnel are trained on GMP/QSR requirements
  • Make recommendations for process improvements and participates in planning and implementing changes to quality and operations process control requirements and the sites as-sociated documentation
  • Review new documents, as well as changes to existing documents, to assure enhanced quality and productivity, while maintaining compliance with FDA requirements
  • Perform trend analysis of data associated with quality problems to detect negative trends and to recommend corrective/preventive actions for problem resolution
  • Other duties as assigned by the General Manager
    Technical & Soft Skills required:
    • Knowledge of organizational processes
    • Competence in laboratory and production testing
    • Knowledge of data analysis techniques
    • Knowledge of audit management techniques
    • Proficiency in English (written and spoken)
    • Communication skills
    • Result-driven orientation
    • Ability to team-working
    • Ability to raise awareness on quality issues
    • Internal and external client-orientation
    • Problem solving ability
    • Detailed knowledge of US GMP/QSR (21CFR820), ISO 9001/13485, and related quality standards
    • Excellent verbal and written communication skills
    • Strong interpersonal skills
    • Ability to train technical, professional, and managerial level personnel
    • Strong knowledge of FDA regulatory requirements and of standard quality assurance practices for manufacturing operations
      Education & Experience:
      • Bachelor's degree in Engineering, Operations or related field of study
      • Minimum of 0-2 years prior experience in Quality Systems at a Quality Assurance or Quality Engineering level
      • Experience with Class II or Class III medical devices is a preferential requirement
        What We'll Provide:
        • More than just, our Total Rewards package connects team members to what matters most. Team members are eligible to begin receiving benefits on their first day of employment. Below are just some of current benefit offerings:
        • Comprehensive Medical, Dental, and Vision Insurance Plans
        • Company Paid Life Insurance
        • Company Paid Short-Term and Long-Term Disability
        • 401(k) with company matching
        • Paid Time Off (including Vacation, Paid Sick Time, and Company Paid Holidays)
        • Maternity/Paternity Leave
        • Professional Development Programs
          About Lima USA:Lima USA is a proud subsidiary of LimaCorporate, a global orthopedic medical device company providing reconstructive and fixation orthopedic solutions to surgeons who face the challenges of improving their patient's quality of life.
          We are committed to the development of innovative products and procedures to enable surgeons to select ideal solutions for every individual patient. Our product range includes large joint primary/revision implants and complete extremities solutions including fixation.
          We aspire to be the leading company in niche orthopedic markets to improve surgeon and patient experience, offering innovative, tailored solutions with established direct subsidiaries in 23 countries across the globe, covering and supporting over 42 countries worldwide! We offer innovative solutions to assist orthopedic surgeons in restoring the eMotion of Motion.
          At Lima USA, we want all of our team members to experience Lima USA as "a place where I belong." Our goal is to embed diversity and inclusion into everything we do, so it becomes part of who we are. As such individuals are recruited, hired, assigned, and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic. Lima USA is an equal opportunity employer.

Keywords: Lima Corporate, Arlington , Quality Assurance Specialist - Document Control, Other , Arlington, Texas

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