Job Opportunity: Senior Quality Leader, Quality/Design Assurance Engineers

Location: On-site (Alden, NY)

Anticipated Start Date: ASAP

Contract Length: 6-12 months minimum

Role Overview:

EPM Scientific is seeking several Quality Specialists to join our client's Quality team. These specialists will provide hands-on support to ensure all duties and responsibilities are met. Key tasks include daily complaint review, investigation reports, adverse event reporting, and maintaining complaint logs and trends.

Key Responsibilities:

• Day-to-day complaint review
• Investigation report preparation
• Adverse event reporting
• Complaint log and trend maintenance

Skills and Knowledge Required:

• Bachelor's Degree
• Minimum of 2 years of experience in Quality Assurance, specifically in complaint processing
• Experience in the medical device industry with knowledge of ISO 13485, FDA 21 CFR 820, and European Union MDD/MDR
• Ability to investigate complaints with minimal guidance
• Strong problem-solving skills and critical thinking abilities
• Good technical writing skills
• Experience with firmware/hardware-related complaint investigations is a plus
• Attention to detail and timeliness
• Excellent verbal and written communication skills
• Proficient with MS Word, Excel, Adobe Acrobat, and other commonly used software systems
• Basic knowledge of Quality Systems (CAPA/non-conformances/SCARs) is a plus
• Ability to work independently and as part of a team
• Positive and energetic team player

If you meet these qualifications and are ready to start immediately, we encourage you to apply!