Quality Technician (Level I, II, III, and Senior)

Description

Join Our Quality Team

We are seeking a motivated and detail-oriented Quality Technician at any career level to support our quality assurance and quality control operations. This posting is designed to build a diverse candidate pool, allowing us to consider applicants with varying levels of experience and expertise. Placement will be determined based on qualifications, demonstrated competencies, and relevant experience.

Whether you are beginning your career in quality, expanding your technical expertise, or bringing advanced experience to lead complex quality activities, we encourage you to apply.

Technician I

• Entry-level quality professional responsible for reviewing quality records and Device History Records (DHRs) for accuracy, completeness, and compliance.
• Performs final product inspections, supports product release activities, conducts in-process testing, and maintains quality documentation.
• Participates in manufacturing support activities while learning applicable quality systems, procedures, GMP requirements, and regulatory standards.
• Typically requires prior quality experience and the ability to follow established procedures with guidance from more experienced team members.

Quality Technician II

• Builds upon Technician I responsibilities with increased ownership of inspection and testing activities.
• Performs incoming inspection of materials and components, environmental monitoring activities, validation and engineering study testing, and initiates nonconformance reports.
• Assists with implementation of procedural revisions and process improvements while contributing to corrective action discussions.
• Demonstrates greater independence, technical proficiency, and understanding of quality systems and manufacturing processes.

Quality Technician III

• Advanced technician responsible for a broader range of quality assurance activities and cross-functional coordination.
• Coordinates third-party testing programs, reviews calibration activities, evaluates equipment maintenance records, and supports product acceptance and release decisions.
• Serves as a technical resource for quality processes, investigations, and compliance activities.
• Provides training and guidance to Quality Technician I and II team members while supporting continuous improvement initiatives.

Senior Quality Technician

• Recognized subject matter expert capable of performing all Quality Technician III responsibilities with a high degree of independence and technical expertise.
• Leads complex quality activities including audits, process improvements, quality investigations, regulatory compliance support, and cross-functional quality initiatives.
• Provides mentorship, training, and leadership within the Quality organization and serves as a key resource for problem-solving and continuous improvement efforts.
• Demonstrates proficiency across all core quality functions and possesses additional specialized capabilities that contribute to departmental and organizational success.

Requirements

Required Qualifications

• Ability to operate and communicate effectively with cross-functional teams.
• Strong documentation and organizational skills.
• Ability to accurately collect and organize data.
• Must be able to perform basic mathematical functions using whole numbers, fractions, and decimals.
• Must be able to compute averages, rates, percent and to draw and interpret bar graphs.
• Ability to read and interpret Standard Operating Procedures (SOPs) and work instructions.
• Proficient in using Microsoft office programs (Word, Excel, and PowerPoint).
• Satisfactorily pass comprehensive background screening.

Preferred Qualifications

• Experience in medical device, pharmaceutical, biotechnology, radiopharmaceutical, manufacturing, or other regulated industries.
• Familiarity with Good Documentation Practices (GDP), GMP, FDA, ISO 13485, or comparable quality standards.
• Associate’s degree in technical or business related field / Bachelor’s degree.
• Working knowledge of 21CFR Part 820 and ISO 13485:2016 regulations and experience with Quality Management Systems.
• Ability to use various measurement equipment/devices (Caliper, Micrometer, Scale, Comparator).

  Physical Demands/Working Conditions

• Works in office space, supply room, laboratory, and/or clean room environments.
• Frequent exposure to hazardous materials requiring appropriate PPE and precautions when working with hazardous materials and chemicals.
• Requires frequent finite hand/eye coordination.
• Largely a stationary role with some moving from place to place.
• Frequent use of a computer, keyboard, mouse, monitor and other office equipment.
• Frequent use of laboratory and manufacturing equipment.
• Occasionally picks up, carries, and moves items up to 50 lbs.
• Some evening and weekend work depending upon workload.

Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of the job.