Quality Engineer (Product Transfer Validation)

Quality Engineer (Product Transfer Project)

• Location: (ONSITE) – Mahwah, NJ (07430) – Up to 10% travel
• Duration: 12 month contract (Contract extension possibilities)
• Type: W2 contract (C2C OR THIRD PARTY arrangements will NOT be considered for this role)
• Pay: Negotiable depending on direct-related experience up to $32 – $37 an hour
• Work Authorization: Must be currently in the United States with active employment authorization documents without current sponsorship transfer requirements. Sponsorship is unavailable for this role.

Job Summary

As a Quality Engineer you will provide quality engineering support in quality assurance, control and preventative activities within operations and other business functions.

• You will be tasked with developing and implementing methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed.
• You will collaborate with the Manufacturing Engineering team, Sterility Assurance Teams, and Design Teams to land new equipment and set up the process for quality and compliance success by implementing appropriate, risk-based process controls and equipment maintenance measures.
• You will advocate and lead the execution of initiatives & projects to enhance quality performance within the business and ensure compliance to regulations and standards.

You will be expected to support:

• Validation projects for new equipment and processes introduced to the plant.
• First Article Inspection (FAI) strategy development, execution, and approvals.
• Standard Operation Procedures (SOP) and Inspection plan creation and updates through the change management system.

MUST HAVE QUALIFICATIONS:

• Bachelor’s Degree – Biomedical Engineering, Mechanical Engineering or related field
• 1 + years of experience in industry required
• Knowledge of Change Management and Quality Management Systems (QMS) principles.
• Firm understanding of Med Device concepts highly desirable.
• Familiarity with ISO 13485, GDP, GMP concept highly desirable.
• Excellent communication skills and attention to detail.
• Self-starter with efficient work style and ability to handle multiple tasks in a fast-paced environment.
• Have knowledge of Risk Based and statistical concepts is desirable.

Work Authorization: Must be currently in the United States with active employment authorization documents without current sponsorship transfer requirements. Sponsorship is unavailable for this role.

Important information: To be immediately considered, please send an updated version of your resume to Deas172@kellyservices.com.

*** (Kelly does not expense relocation/interview costs)**

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