Quality Engineer

  • location: Allen, TX
  • type: Temp to Perm
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job description

Quality Engineer

job summary:
Summary:

Responsible for maintaining and improving the Quality Management System. Performs activities to support quality aspects of design and development, manufacture, and post-production of components and finished products. Conducts Corrective and Preventive Action activities to investigate causes of non-conformance, determine root cause and implements corrective actions to eliminate quality problems. Provides support and leadership to PIT teams focused on CAPA. Supports supplier quality program by performing audits, managing supplier metrics, and managing supplier correction action plans. Develops various product tests and conducts data analysis. Develops qualification test protocols and generates reports as needed. Provides guidance on engineering projects. Supports the internal and external quality audit program. Uses statistical tools to analyze data, make acceptance decisions, and improve process capability.

 
location: Allen, Texas
job type: Contract
work hours: 8am to 5pm
education: Associates
 
responsibilities:
Requirements:

  • Bachelor of Science degree in a technical area such as Science, Engineering, Math or equivalent experience.
  • Minimum of 5 years of related experience in regulated environment, preferably medical device.
  • Familiarity working within FDA Quality System Regulation, MDD, ISO 9001, ISO 13485 and 14971.
  • Understanding and/or familiarity with ISO, TUV, and FDA requirements.
  • Excellent writing and communication skills. Must possess technical writing, project management and fundamental problem-solving skills.
  • A demonstrated comfort using personal computers with strong experience using word processing, spreadsheet, data management and/or design of experiments software programs.
  • Comfort with group/individual presentations.
  • Previous experience performing laboratory and/or mechanical testing required.
  • Previous experience with quality related software (Q-Pulse, Trackwise, etc.) applications desired.
  • Prior experience in auditing desired. Lead Auditor certification (American Society for Quality (ASQ), Certified Quality Engineer (CQE)) or training preferred.
  • Ability to travel up to 10% of the time
 
qualifications:
Duties:

  • Collect, analyze, trend and communicate quality data throughout the organization. Provide Quality technical guidance to project teams by representing quality interests and concerns. Lead quality focused projects as part of continuous improvement and PIT initiatives.
  • Adhere to and ensure compliance with Quality System objectives (SOPs, work instructions, drawings, technical documentation, current Good Manufacturing Practices (cGMPs)).
  • Responsible for supporting and identifying improvement initiatives in the quality management system throughout the organization (NCMRs, Complaints, CAPAs, ECOs). Performs activities to support quality aspects of design and development, manufacture, and post-production of components and finished products.
  • Execute Risk Assessments, collect supporting information, generate risk management files, and provide recommendations for management consideration for new and existing products.
  • Lead departmental effort in Corrective and Preventative Action (CAPA) activities (root causes, investigations, implementations of corrective actions and completion). Provides support and leadership to teams focused on CAPA initiatives.
  • Maintain, investigate, and trend product complaint files and respond to all customer complaints.
  • Manage nonconforming material reports (NCMRs) to investigate causes of quality problems identified at incoming inspection, manufacturing and final QC inspection and implement effective corrective actions for nonconforming materials.
  • Develop/write protocols and coordinate the testing for validation activities, component qualification activities, IQ/OQs, test method validations, and Gage R&R studies.
  • Comfort developing and analyzing statistical data and product specifications.
  • Experience in performing internal or external audits and/or customer or regulatory audits.
  • Responsible for Supplier Quality deliverables and interaction. Identifies supplier related problems and opportunities. Implements controls and continuous improvement initiatives to improve supplier quality.
  • Recommend modifications of existing quality or production standards to achieve optimum quality within limits of equipment capability.
  • Works under general supervision. Relies on instructions and pre-established guidelines to perform the functions of the job. Assume additional responsibilities as necessary as the discretion of QA.
 
skills: Duties:

  • Collect, analyze, trend and communicate quality data throughout the organization. Provide Quality technical guidance to project teams by representing quality interests and concerns. Lead quality focused projects as part of continuous improvement and PIT initiatives.
  • Adhere to and ensure compliance with Quality System objectives (SOPs, work instructions, drawings, technical documentation, current Good Manufacturing Practices (cGMPs)).
  • Responsible for supporting and identifying improvement initiatives in the quality management system throughout the organization (NCMRs, Complaints, CAPAs, ECOs). Performs activities to support quality aspects of design and development, manufacture, and post-production of components and finished products.
  • Execute Risk Assessments, collect supporting information, generate risk management files, and provide recommendations for management consideration for new and existing products.
  • Lead departmental effort in Corrective and Preventative Action (CAPA) activities (root causes, investigations, implementations of corrective actions and completion). Provides support and leadership to teams focused on CAPA initiatives.
  • Maintain, investigate, and trend product complaint files and respond to all customer complaints.
  • Manage nonconforming material reports (NCMRs) to investigate causes of quality problems identified at incoming inspection, manufacturing and final QC inspection and implement effective corrective actions for nonconforming materials.
  • Develop/write protocols and coordinate the testing for validation activities, component qualification activities, IQ/OQs, test method validations, and Gage R&R studies.
  • Comfort developing and analyzing statistical data and product specifications.
  • Experience in performing internal or external audits and/or customer or regulatory audits.
  • Responsible for Supplier Quality deliverables and interaction. Identifies supplier related problems and opportunities. Implements controls and continuous improvement initiatives to improve supplier quality.
  • Recommend modifications of existing quality or production standards to achieve optimum quality within limits of equipment capability.
  • Works under general supervision. Relies on instructions and pre-established guidelines to perform the functions of the job. Assume additional responsibilities as necessary as the discretion of QA.

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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