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Quality Assurance Manager

Company: X-Nav Technologies, LLC
Location: Lansdale
Posted on: June 25, 2022

Job Description:

X-Nav Technologies is a small, dynamic medical device company focused on delivering advanced treatment solutions to the dental market. We design, manufacture, market, and sell image-guided surgical navigation systems from our headquarters in Lansdale, PA. We were founded in 2012. Since then, our company has become a market leader with well over 1,700 X-Guide units sold and over 200,000 implants placed. The X-Guide boasts regulatory clearance in more than 42 countries and is protected by over 20 patents.The company was founded by three partners who bring proven success in dental technology development, sales, and clinical use. Our talented team consists of advanced PhD and MS Engineers with experience in Image Guided Surgery, Implant Planning, and CT technology along with expert knowledge in Quality, Regulatory, ISO 13485 and FDA Requirements.Department: Quality AssuranceReports to: Quality Assurance LeaderResponsibilities:

  • Responsible for Quality Assurance and Quality Engineering actions and deliverables with respect to design control, validation remediation, coordination of documentation, and CAPA Resolution (if required).
  • Develops and establishes quality systems and procedures, inspection plans, quality performance trends, statistical plans, and technical quality plans in compliance with relevant regulatory requirements and ISO standards.
  • Initiate and recommend improvements to the quality system, product design, processes, documentation, materials, and manufacturing processes to improve product quality or when gaps are identified through audits and departmental reviews.
  • Supervise employees in quality department. Delegate tasks and duties related to quality control. Responsible for training, developing, motivating, reviewing, and counseling subordinate staff. Effectively communicate a variety of personnel actions. e.g., employment, termination, performance and salary reviews, disciplinary actions, scheduling and/or approving overtime.
  • Estimate personnel needs, assign work, meet completion dates, and ensure consistent application of organizational policies.
  • Mentor Engineers in Root Cause analysis and effective Corrective Actions implementation.
  • Perform Data Mining, Trending, Graphing, and Statistical Data Analysis to assess quality performance or cost-of-quality, identify quality problems, and help improve internal efficiency. Supply quality metrics as requested.
  • Support state of the art processes for inspection, including incoming, in-process, and/or final inspections. Ensure compliant documentation, procedures, methods, techniques, frequencies, and documentation.
  • Attend and contribute to Materials Review Board meetings. Determine disposition of non-conforming materials and contribute to root cause investigations and corrective actions related to design or use issues.
  • Participate in audits: Internal, Supplier, and 3rd Party.
  • Approve documents under change control as necessary.
  • Perform other related duties as assigned by the Quality Assurance Leader. -Qualifications:
    • Bachelor's Degree in Quality, Engineering, Regulatory Affairs or closely related field from an accredited university
    • Minimum of five (5) years of professional Quality Assurance experience in medical device manufacturing required.
    • Familiarity with ISO 13485, 21 CFR 820 and MDD/MDR regulations.
    • Applicable industry/professional certification desired.
    • Knowledge of medical Good Manufacturing Practices (GMP's). -Desired Skills / Abilities:
      • Must be able to work with all functional groups.
      • Excellent verbal and written communication skills.
      • Strong attention to detail and accurate record keeping.
      • Strong organization abilities and problem-solving skills.
      • Advanced computer skills including word processing and spreadsheet / data tracking and analysis.
      • Familiarity with Agile PLM Software desired
      • Experience supervising employees.
      • Experience with investigative root cause analysis, non-conformances, and deviations.
      • Practical application of statistical techniques, including acceptance sampling, SPC, pareto charting
      • Root Cause Analysis and implementation of appropriate countermeasures and corrective actions.

Keywords: X-Nav Technologies, LLC, Philadelphia , Quality Assurance Manager, Executive , Lansdale, Pennsylvania

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