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!

• 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 Smart Scope).
• 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
  .

• 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 Smart Scope preferred)
• Quality tools (FMEAs, Control Plans, Root Cause Analysis, etc.)
• Hands-on experience with inspection tools, gages, and metrology equipment.
• Proficiency with Solid Works 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.

• 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)