Job Description

Mechanical Engineer

• Hanover, MD
• Contract - 6-12 months +
• On-Site Position

PTS Advance is seeking a Mechanical Engineer to support a key client in Maryland. This role focuses on overseeing the handover process for mechanical systems, ensuring compliance with quality standards and operational requirements. The ideal candidate will have a strong background in project management, quality control, and process improvement within a regulated industry.

Key Responsibilities:

• Oversee the handover of mechanical systems, ensuring all documentation, validation, and compliance requirements are met.
• Lead the implementation of a new QMS system, ensuring smooth integration and adherence to industry standards.
• Develop and manage an effective complaint handling system, tracking issues through resolution.
• Utilize trending techniques and data analysis to support decision-making in quality investigations.
• Collaborate with facility leadership to resolve open quality issues and provide training on QMS implementation and sustainment.
• Drive BOM cleaning activities and alternative BOM identification to strengthen the supply chain using automation tools such as Excel VBA and Power BI.
• Support equipment validation (IQ, OQ, PQ), packaging and sterilization validation, ISTA shipping studies, and risk-based quality control planning.
• Optimize manufacturing instructions and define critical-to-quality (CTQ) factors for effective quality control.

Qualifications & Skills:

• Education: BS/MS in Mechanical Engineering.
• Certifications: Project Management Certification, Six Sigma Green Belt.
• Technical Skills: SolidWorks, Visio, MS Project, Excel VBA automation, SPC analysis, Lean techniques, MySQL, Smartsheets, JIRA, GD&T, ANSYS, Pro-E, AutoCAD, MATLAB.
• Quality & Compliance: Root cause analysis (8D, 5 WHYs, Fishbone), PFMEA/DFMEA, cGMP, ISO 9001, ISO 13485.
• Soft Skills: Strong problem-solving abilities, adaptability, time management, teamwork, and a self-driven approach.

This is an excellent opportunity for a mechanical engineer who thrives in a fast-paced, technical environment and is passionate about process optimization and quality assurance.

Interested? Apply today and take the next step in your career with PTS Advance!

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