What are the responsibilities and job description for the Mechanical Engineer position at PTS Advance?
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.
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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