Product Quality Engineer II - Burlington - ConforMIS

    ConforMIS
    ConforMIS Burlington

    16 hours ago

    $95,000 - $145,000 (USD) per year *
    Description

    Job Summary:


    The Product Quality Engineer II will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight.


    Essential Duties and Responsibilities:

    • Develop and maintain strong internal working relationships across Conformis.
    • Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals.
    • Prioritize and plan work activities; adapt for changing conditions.
    • Assist in maintaining the quality system in accordance with applicable regulatory requirements.
    • Identify quality system process improvements and implement solutions.
    • Lead or assist with the Corrective Action/Preventive Action (CAPA) program.
    • Lead or assist with the Customer Complaint system by performing complaint investigations, including root cause analysis.
    • Assist with product inspections as needed.
    • Perform Internal Quality Audits of the quality system
    • Participate in supplier selection and approval process, including leading supplier audits and review of quality data.
    • Perform investigations of non-conformances and drive corrective actions.
    • Participate on cross-functional product development teams.
    • Participate in product/process validations.
    • Perform risk assessments, gathering cross-functional team input.
    • Employ statistical techniques and rationale in decision-making activities driven to support non-conformance trending, CAPA effectiveness, part qualification, and process monitoring.
    • Establish and trend quality metrics and data.
    • Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements.
    • Other responsibilities as assigned.

    Qualifications:

    • Bachelor of Science in Engineering, Science, or Biomedical.
    • 2+ years of Quality Assurance/Quality Engineering experience in the medical device industry and/or experience in an FDA regulated environment is required.
    • Knowledge of FDA 21 CFR Part 820 and ISO 13485, preferred.
    • ASQ certification (Certified Quality Engineer, Certified Quality Auditor, Certified Biomedical Auditor) a plus.

    Skills, Abilities, Competencies Required:

    • Excellent written and verbal communication skills.
    • Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
    • Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness.
    • Strong organizational, analytical, and time-management skills.
    • Able to self-motivate and work both independently and as part of a team.
    • Must have a solid knowledge of Microsoft office.
    • Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail.
    • Demonstrated proficiency with FDA and ISO standards for Medical Devices.
    * This salary range is an estimation made by beBee
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