Job Title: Quality Engineer II

What You ll Do:

As a Quality Engineer II, you will be responsible for ensuring product quality, reliability, and compliance with regulatory requirements throughout the product lifecycle. Leveraging your experience and technical expertise, you will support quality assurance activities, drive process improvements, and contribute to the development and implementation of quality management systems.

Functions:

Support the development and implementation of quality management systems (QMS), including policies, procedures, standards, and documentation, to ensure compliance with regulatory requirements and industry standards.
Participate in product development and design control activities, including risk management, design verification/validation, and change control, to ensure product quality and regulatory compliance.
Conduct root cause analysis, failure investigations, and CAPA (Corrective and Preventive Action) activities to address quality issues, non-conformances, and customer complaints.
Perform quality engineering activities, including statistical analysis, process capability studies, and design of experiments (DOE), to optimize processes and improve product quality and reliability.
Collaborate with cross-functional teams, including R&D, manufacturing, supply chain, and customer service, to resolve quality issues, implement corrective actions, and support continuous improvement initiatives.
Lead and participate in internal and external audits, inspections, and regulatory assessments to ensure compliance with quality standards, regulations, and customer requirements.
Provide technical support and guidance to manufacturing operations, suppliers, and other stakeholders to ensure adherence to quality standards and specifications.
Required Qualifications:

Bachelor s degree in Engineering, Science, or related field.
3-6 years of experience in quality engineering, quality assurance, or a related role, preferably in a regulated industry such as medical devices, pharmaceuticals, or aerospace.
Strong knowledge of quality management principles, methodologies, and tools, including statistical process control (SPC), root cause analysis, and risk management.
Experience with quality management systems (QMS) and regulatory requirements, such as ISO 13485, FDA QSR, and EU MDR.
Proficiency in statistical analysis software (e.g., Minitab) and quality engineering tools and techniques.
Excellent problem-solving and analytical skills, with the ability to analyze complex issues, identify root causes, and implement effective solutions.
Effective communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.
Preferred Skills:

Master s degree in Quality Engineering, Industrial Engineering, or related field.
Professional certification in quality engineering or related areas (e.g., ASQ Certified Quality Engineer, Six Sigma Green Belt).
Experience with risk management methodologies (e.g., FMEA, Hazard Analysis).
Familiarity with validation and verification processes and protocols.
Knowledge of Lean Six Sigma methodologies and tools for process improvement.
Previous experience with quality management software/systems (e.g., TrackWise, MasterControl).
Programming experience

Shift hours: 7:00 to 3pm or 5 to 1pm CST
Working days - Monday to Friday

If ITAR/EAR is noted above:Please note that this position is subject to export control regulation. Unless an exemption applies or access to ITAR/EAR controlled sites, products and information can be avoided, candidate(s) selected and extended a conditional offer of employment for ITAR/EAR controlled positions will be required to demonstrate they are a US Person* within the meaning of the law OR obtain an export control license from the applicable federal agency. If an export license is required for compliance, employees will be required to obtain and maintain such licenses. Randstad will not facilitate or provide such licenses. If a candidate cannot comply with applicable requirements for ITAR/EAR compliance within the time required, a conditional offer may be rescinded. Candidates who do not meet the ITAR/EAR requirements for this particular position or choose not or choose not to pursue such positions are not disqualified from, and are encouraged to, apply for other opportunities with Randstad. Nothing in this posting should be interpreted as limiting applications based on nationality or citizenship status. *A U.S. Person under export control laws includes a U.S. citizen, U.S. national, U.S. permanent resident, or protected individual who is not a US citizens or US national, but who has been lawfully admitted for temporary residence in the U.S. as a refugee or asylee under U.S. law