Senior Quality Technician

Job Title: Quality Technician II / Quality & Regulatory Services Associate

Location: Onsite – Tewksbury, MA (Hybrid possible after training)

Schedule: Full-Time | M–F | 8am–5pm or 10am–7pm

Duration: Long-term

Interviews: 1st Round Video (30 min) → 2nd Round Onsite Panel.

Position Overview

The Quality & Regulatory Services (QRS) Associate provides front-line support for both internal and external customers on quality and regulatory inquiries. This role acts as a key liaison between customers and cross-functional departments and supports ongoing QRS processes, documentation, communication, and complaint triage.

The ideal candidate is organized, customer-oriented, detail-focused, and experienced in quality/regulatory environments—preferably within the medical device or clinical industry.

Key Responsibilities

Customer Support & Communication

• Serve as the first point of contact for customer quality and regulatory inquiries.
• Perform first-level triage of incoming customer complaints and QRS email queue.
• Quickly identify duplicates, assign issues to the correct teams, and escalate urgent items according to QRS guidelines.
• Maintain professional, clear, and timely communication with customers and internal stakeholders.

Cross-Functional Collaboration

• Collaborate daily with Quality, Regulatory, Customer Service, Sales, Scientific Support, Marketing/Communications, Business Operations, and Supply Chain teams.
• Support continuous improvement initiatives focused on enhancing customer experience and internal process efficiency.

Project & Process Support

• Assist with QRS process management and project activities.
• Follow established guidelines, templates, and documentation standards.
• Support reporting, metrics, and data tracking as needed (for candidates with reporting skills).

Required Qualifications

• HS Diploma/GED or Associate’s Degree required.
• 2–4 years of experience in a customer-facing, manufacturing, or quality/regulatory role—preferably in medical device or clinical industries.
• Strong prioritization skills with proven ability to manage time-sensitive inquiries.
• Proficiency with Microsoft Office and ability to learn new systems quickly.
• Excellent written and verbal communication; professional, courteous, and articulate.

Preferred Qualifications

• Experience with systems such as ETQ, SharePoint, Salesforce, or PeopleSoft.
• Experience creating and maintaining reports or metrics.
• Multilingual skills (highly preferred).
• Interest in innovation, automation, and continuous improvement.

Soft Skills

• Maintains composure under pressure and handles sensitive situations professionally.
• Strong judgment, business acumen, and customer-first mindset.
• Demonstrated teamwork and positive interaction across diverse departments.
• Ability to communicate effectively with customers from various industries and regions.

Performance Expectations

• Meets daily targets and response timelines.
• Follows QRS guidelines and standard templates.
• Escalates issues appropriately and promptly.
• Consistently demonstrates professional, positive, and cooperative behavior.