Quality Assurance Specialist-Junior

Indotronix International Corporation; Bridgewater Township (NJ); On-site; USD 45,000 - 65,000; Full time

Benefits offered by this job

Hands-on experience

Career growth

Modern office

Supportive team culture

Job summary

Indotronix International Corporation in Bridgewater, NJ, is seeking a Quality Assurance Specialist - Junior to ensure quality and safety of regulated products in life sciences.

This entry-level role handles complaint management, customer communication, and cross-functional collaboration with Quality, Engineering, and Operations to support audits and continuous improvement.

Qualifications

• Bachelor's degree in Science, Math or Engineering.
• Up to 2 years' experience in a regulated medical device, biologics, or pharmaceutical environment.
• Familiarity with cGMP and complaint management regulations (21 CFR 820, 803, 210/211, ISO 13485, EU MDR, etc.).
• Proficient in Microsoft Office (Excel, Word, PowerPoint).
• Excellent organizational, time management, analytical, and interpersonal skills.
• Strong written and verbal English communication abilities.
• Ability to follow documented procedures and read technical documentation.

Responsibilities

• Capture, review, and analyze product complaints to ensure timely and accurate resolution.
• Communicate directly with customers via phone and email to address concerns and document feedback.
• Identify trends and process metrics to proactively improve product quality and service.
• Distinguish between product complaints, adverse events, medical information requests, and regulatory submissions.
• Collaborate with Field, Quality, Engineering, and Operations teams for efficient complaint processing.
• Initiate, coordinate, and summarize investigations related to product complaints.
• Perform product return evaluations as needed; escape safety and quality concerns to management.
• Support audits and regulatory inspections by providing documentation and expertise.
• Maintain adherence to global quality guidelines, standards, and regulations throughout complaint management.
• Participate in continuous improvement initiatives and contribute to departmental goals.

Skills

Analytical skills

Interpersonal skills

Time management

Organizational skills

Database software familiarity

English communication

Education

Bachelor's degree (Science, Math, or Engineering preferred)

Tools

Microsoft Office

Job description

Job Summary: Quality Assurance Specialist - Junior

Location: Bridgewater, NJ, 08827, United States

About the Role

Join a dynamic team as a Quality Assurance Specialist - Junior, where you will be instrumental in ensuring the quality and safety of commercial products in a regulated life sciences environment. This entry-level role focuses on the daily management of product quality complaints and offers you the chance to develop expertise in compliance, customer interaction, and cross-functional collaboration within the medical device, biologics, and pharmaceutical sectors.

Responsibilities

• Capture, review, and analyze product complaints to ensure timely and accurate resolution
• Communicate directly with customers via phone and email to address concerns and document feedback
• Identify trends and process metrics to proactively improve product quality and service
• Distinguish between product complaints, adverse events, medical information requests, and regulatory submissions
• Collaborate with Field, Quality, Engineering, and Operations teams for efficient complaint processing
• Initiate, coordinate, and summarize investigations related to product complaints
• Perform product return evaluations as needed; escape safety and quality concerns to management
• Support audits and regulatory inspections by providing documentation and expertise
• Maintain adherence to global quality guidelines, standards, and regulations throughout complaint management
• Participate in continuous improvement initiatives and contribute to departmental goals

Required Skills and Experience

• Bachelor's degree (Science, Math, or Engineering preferred)
• Up to 2 years' experience in a regulated medical device, biologics, or pharmaceutical environment
• Familiarity with cGMP and complaint management regulations (21CFR 820, 803, 210/211, ISO 13485, MDD, EU MDR, etc.)
• Proficient in Microsoft Office (Excel, Word, PowerPoint)
• Excellent organizational, time management, analytical, and interpersonal skills
• Strong written and verbal English communication abilities
• Ability to follow documented procedures and read technical documentation

Preferred Skills

• Experience supporting audits and regulatory inspections
• Direct experience with complaint management or product return evaluations
• Knowledge of device, drug, or biologic operational processes
• Familiarity with database software

Benefits

• Gain hands-on experience in a fast-paced, highly regulated industry
• Collaborate with cross-functional teams and build valuable professional networks
• Opportunities for career growth and advancement within quality assurance and related fields
• Modern office environment with daily use of computer and phone
• Supportive team culture and ongoing learning opportunities