Quality Engineer II (MedTech)

TL;DR

Quality Engineer II (MedTech): Providing quality engineering support for the Access, Instrumentation, and Powered Focus Factory with an accent on process performance, nonconformance investigations, and CAPAs. Focus on reducing defects and complaints through data-driven quality tools and ensuring strict compliance with regulatory standards.

Location: 100% onsite in North Haven, CT. Candidates must possess unrestricted U.S. work authorization at the time of hire.

Salary: $79,200 - $118,800 USD

Company

A global healthcare technology leader dedicated to alleviating pain, restoring health, and extending life through medical innovation.

What you will do

• Provide daily quality engineering support on the manufacturing floor to resolve quality issues immediately.
• Lead root cause investigations, nonconformance management, and Corrective and Preventive Actions (CAPA).
• Develop and maintain inspection and testing methods to ensure product quality and process consistency.
• Analyze process performance and yields using statistical methods to drive defect reduction.
• Ensure compliance with hirify.global Quality System, ISO 13485, and FDA QSR regulatory standards.
• Coach operators and engineers on quality system requirements and continuous improvement.

Requirements

• Bachelor’s Degree in Engineering, Science, or a technical field with 2+ years of work experience in Engineering or Quality.
• Alternatively, an Advanced Degree in Engineering, Science, or a technical field.
• Unrestricted U.S. work authorization is required (sponsorship is not offered for this level).

Nice to have

• Experience with process validation (IQ, OQ, TMV, PQ).
• Familiarity with statistical tools like Minitab, SPC, and trend analysis.
• Six Sigma training or certification.
• Working knowledge of ISO 13485 and FDA QSR standards.
• Experience supporting internal and external audits.

Culture & Benefits

• Comprehensive health, dental, and vision insurance with HSA and FSA options.
• 401(k) plan with employer contribution and match.
• hirify.global Incentive Plan (MIP) short-term incentive.
• Paid time off, paid holidays, and tuition reimbursement.
• Employee Stock Purchase Plan and global well-being program (Simple Steps).