Compensation: $85,000 – $100,000 Per Year
Full Benefits: Unspecified
Relocation Expenses: No
Interview Expenses: No
Location: Danvers, MA
Job Type: Direct Hire
Remote: No Remote
Total Openings: 1

In this role, you’ll play a crucial part in maintaining product quality and regulatory compliance while working
closely with cross-functional teams in engineering, manufacturing, and supplier quality. This is an opportunity
to contribute to the full product lifecycle—from design and development to production and post-market quality
—while growing your expertise in an industry that makes a real difference in patient outcomes.

What You’ll Do:
 Ensure the integrity of the quality system by applying engineering principles to manufacturing and
product development.
 Collaborate with R&D and manufacturing teams to refine designs and processes, contributing to risk
analysis, verification and validation, and process improvements.
 Apply statistical methods such as Gage R&R, Cpk, ANOVA, and DOE to analyze quality trends and
drive improvements.
 Use root cause analysis tools like 5-Why, FMEA, and 8D to troubleshoot and prevent quality issues.
 Conduct internal and supplier audits, support incoming inspection processes, and assess non-
conformances.
 Review and approve engineering change orders, work instructions, and specifications to ensure
compliance with industry standards.
 Assist in regulatory compliance, including adherence to FDA 21 CFR 820 and ISO 13485.
 Support sterilization monitoring and environmental controls.
 Lead and participate in continuous improvement initiatives to optimize quality processes.
 Some travel required for supplier support and quality audits.

What You Bring:
 Bachelor’s degree in Mechanical or Biomedical Engineering (or equivalent experience).
 3-5+ years of experience in quality or engineering for medical devices.
 Strong problem-solving skills with hands-on experience in quality tools and methodologies.
 Knowledge of regulatory standards (FDA 21 CFR 820, ISO 13485).
 Excellent attention to detail and ability to manage quality records accurately.
 Lean/Six Sigma experience is a plus.
 CQE/CQA certification or biomedical auditing experience is beneficial but not required.