Lead Quality Engineer | Jobs with TheMasonGroup

Lead Quality Engineer Accepting Candidate

Location: Lansdale, Pennsylvania Country: United States Job Type: Permanent (Full Time)
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Published Date: 08-05-2019   |   Print Job
Sean M. Hill

Sean M. Hill is recruiting this position.

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Job Description

Lead Quality Engineer

The Lead Quality Engineer Responsible for ensuring product & service meets the established standards of quality including reliability, usability and performance. Oversees inspection and testing of materials, parts, and products to ensure adherence to established standards of strength, quality, and endurance. Also responsible for operating mechanical and electrical test equipment to check apparatus for conformance to standard requirements. A Lead Quality Engineer has authority for personnel actions and oversees most day-to-day operations of the Quality group.

Responsibilities

  • Draft quality assurance policies and procedures
  • Interpret and implement quality assurance standards
  • Evaluate adequacy of quality assurance standards
  • Devise sampling procedures and directions for recording and reporting quality data
  • Review the implementation and efficiency of quality and inspection systems
  • Plan, conduct and monitor testing and inspection of materials and products to ensure finished product quality
  • Document internal audits and other quality assurance activities
  • Investigate customer complaints and non-conformance issues
  • Collect and compile statistical quality data
  • Analyze data to identify areas for improvement in the quality system
  • Develop, recommend and monitor corrective and preventive actions
  • Prepare reports to communicate outcomes of quality activities
  • Identify training needs and organize training interventions to meet quality standards
  • Coordinate and support on-site audits conducted by external providers
  • Evaluate audit findings and implement appropriate corrective actions
  • Monitor risk management activities
  • Responsible for document management systems
  • Assure ongoing compliance with quality and industry regulatory requirements
  • Responsible for the training & performance review of personnel in department.

Experience:

  • Quality inspection, auditing, & testing experience
  • ISO or ISO 13485, Medical Device experience, preferred, not required.
  • Manufactured components experience
  • SPC- Statistical Process Control experience preferred
  • Leadership, mentoring, coaching and training
  • Experience with implementation of corrective action programs
  • Product or industry-specific experience
  • Strong computer skills including Microsoft Office and databases
  • Knowledge of tools, concepts, and methodologies of QA

Education

  • Bachelor’s degree preferred or 5 years of relevant experience
  • Certifications including Quality Auditor, Quality Engineer, Quality Improvement Associate, Six Sigma would be preferred, not required.
  • Status:
    Accepting Candidate
  • No. of Openings:
    1
  • Skills

    QUALITY ENGINEER: 5 years

    Documentation: 5 years

    Quality Assurance: 5 years

    Manufacturing: 3 years

    SPC: 2 years

    Leader: 2 years

    Risk Management: 2 years

    QA Methodoligies: 2 years

    Risk Management: 2 years

    Statistical Process Control: 2 years

    ISO 13485: 1 years

    ISO: 1 years

    Statistical Process Analysis: 1 years

    Statistical Process: 1 years

    Medical Device Exp: 1 years

    Technical: 1 years

    Test Equipment: 1 years

    Process Improvement: 1 years

    Procedural Orders: 1 years

    Customer Complaint: 1 years

    Risk & Controls Assessments: 1 years

    Internal Auditing: 1 years

    Six Sigma: 1 years