Sr. Quality Engineer

NOTICE OF FILING

Employer: BioMed Laboratories, LLC

Job Title: Sr. Quality Engineer

Job Location: 8181 Eastpoint Dr., Suite 300, Dallas, TX 75227

Job Type: Full-time, 40 hours a week, Monday – Friday

Duties:

• Lead Quality improvement efforts by identifying quality bottlenecks and corrective measures to eliminate this.
• Writing CAPAs, methods to capture quality metric data and performs appropriate analysis to effectively monitor and enhance the Quality Management System (QMS).
• Assure new or modified processes or documents conform to quality standards and establishes compliance with the quality system.
• Work with Production Management to reduce and control Manufacturing process defects (scrap, nonconforming material, and customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.
• Develop and implement product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members.
• Work with Process Engineer to develop and implement Process Monitoring Systems by identifying critical process and devising methods to reduce process variation in order to reduce/eliminate the cause of defects.
• Evaluate product performance, identify areas of improvement, and recommend solutions to ensure product quality.
• Analyze quality control data and develop reports to identify trends and recommend corrective actions.
• Coordinate and collaborate with internal departments to resolve quality issues.
• Interfacing with Regulatory, Notified Body or Client Audits and assessing possible findings and responding to these in a timely manner.
• Ensure compliance with applicable industry standards and regulations.
• Stay up to date with best practices and industry developments related to quality assurance.
• Train and mentor junior quality assurance engineers.

Requirements:

• Bachelor's degree (or foreign equivalent) in Computer Engineering, Systems and Industrial Engineering, or related field of study and eight (8) years of experience as as a Sr. Quality Systems Engineer, Sr. Quality Assurance Engineer -Design Transfer, Quality Assurance Engineer, Quality Systems Manager, Quality Systems Coordinator, Site CAPA Coordinator, or related role where experience was gained. Also requires 8 years of experience in the following:
  • Quality Assurance experience, auditing experience and demonstrated knowledge using quality tools/methodologies such as process and equipment validations (IQ/OQ/PQ);
  • Experience applying CAPA and root-cause analysis tools (RCA) tools such as 5-whys, Fishbone/Ishikawa, FMEA, DOE and fault-tree analysis, and other structured problem-solving methods, as well as applying statistical process control (SPC) methodologies including control charts, process capability analysis (Cp, Cpk, Pp, Ppk), capability studies for special-cause versus common-cause variation, Pareto analysis, trend analysis, and gauge R&R (MSA), and the development and application of sampling plans (ANSI/ASQ Z1.4, ISO 2859), using data analysis software tools such as Minitab and Excel;
  • FMEA development and maintenance;
  • FDA, ISO and global regulatory standards applicable to medical devices, OTC drugs and cosmetics to ensure compliance across product development and QMS activities;
  • Implementing, maintaining, and continuously improving QMS frameworks to drive consistent product quality and operational excellence;
  • Lean and Six Sigma methodologies, with practical experience applying process improvement tools to improve product quality and operational performance;
  • Applying regulatory and industry standards including 21 CFR Part 820, ISO13485, 21 CFR Part 210/211 and 21 CFR Part 11;
  • Supporting manufacturing and quality activities for medical devices, OTC drugs or cosmetics, including understanding of specific cGMP (and other regulatory) requirements and standards; and
  • Implementing and maintaining Quality Management System (QMS) elements such as Design Controls or Non-Conformances, CAPA, Complaint Handling and Document Control.

Contact: E-Mail resume to: talentacquisition@mativ.com and reference the job title and location.