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)
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