Quality Assurance Manager
Company: X-Nav Technologies, LLC
Posted on: June 25, 2022
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
- 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
- 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
- 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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