Senior Quality Engineer

We are seeking a dedicated and experienced Senior Quality Engineer to join our dynamic team. This is a critical and highly visible role —you’ll be the primary Quality Engineer onsite and a key driver of quality excellence across the organization. This is a direct hire, permanent position with a competitive salary and comprehensive benefits package.

We’re looking for a self-motivated professional with hands-on experience in medical device manufacturing, ISO 13485 , and injection molding environments . If you’re passionate about continuous improvement, quality systems, and leading cross-functional quality initiatives, we want to hear from you! Key Responsibilities Develop, implement, and maintain Quality Management System elements (e.g., Corrective Actions, CAPA, Continuous Improvement, Training, Audits).

Lead quality improvement initiatives and promote a culture of quality throughout the organization. Support and lead new product introductions , APQP processes, and program launches. Develop and analyze SPC, DOE, Gage R&R , and process validation (IQ, OQ, PQ) data.

Lead and mentor Quality Inspectors; act as liaison with suppliers and customers on quality matters. Interpret and apply GD&T standards; review and approve engineering drawings and specifications. Develop measurement methods, fixtures, and automated inspection programs.

Program and utilize vision inspection systems (QVI OGP SmartScope). Utilize and support Quality modules within ERP systems (preferably iQMS). Develop and maintain quality documentation, including Process Flow Charts, Control Plans, FMEAs, and Work Instructions.

Ensure compliance with ISO 9001, ISO 13485, and applicable FDA regulations . Required Qualifications Bachelor’s degree in a technical or engineering field (or equivalent relevant experience). Minimum of 3+ years of experience in Quality Engineering , preferably in a medical device or regulated manufacturing environment.

Strong working knowledge of: ISO 9001, ISO 13485, and cleanroom standards GD&T, SPC, Gage R&R, DOE, and Capability Analysis Vision systems (QVI OGP SmartScope preferred) Quality tools (FMEAs, Control Plans, Root Cause Analysis, etc.) Hands-on experience with inspection tools, gages, and metrology equipment. Proficiency with SolidWorks and ERP systems (iQMS a plus). Excellent communication (written and verbal), leadership, and analytical skills.

Experience working in injection molding environments is highly preferred. FDA regulatory experience and PC-DMIS CMM programming are a plus. Benefits 401(k) with Company Match Paid Time Off and 9 Paid Holidays Tuition Reimbursement & Professional Development Health Reimbursement & Flexible Spending Accounts Dependent Care Account Life Insurance Employee Assistance Program Salary: $95,000–$120,000 per year Schedule: Monday–Friday, Day Shift (8 AM–5 PM) Location: Danvers, MA (Occasional travel to Fiskdale, MA) #J-18808-Ljbffr