Quality Engineer III

Advantage Technical

Indiana (PA)

On-site

USD 110,000 - 120,000

Full time

14 days+

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Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A prominent staffing agency is seeking a Quality Engineer III in Indiana. In this role, you will support quality initiatives in FDA-regulated environments, ensure compliance, and mentor junior engineers. Ideal candidates have extensive experience in the medical device industry, strong technical writing skills, and a collaborative approach. This contract position offers full-time hours with competitive compensation.

Qualifications

Prior experience in the medical device industry is required.
Experience working with quality systems such as CAPA, NCR, validation, and process controls.
Comfortable working in a fast-paced, collaborative team.

Responsibilities

Lead or support departmental and cross-functional engineering initiatives related to quality and compliance.
Serve as a mentor and provide technical guidance to junior engineers and technicians.
Investigate, recommend, and implement best-in-class quality engineering practices.

Skills

Strong technical writing skills

Detail-oriented

Analytical thinker

Experience with quality systems

Familiarity with FDA regulatory standards

Education

Bachelor's degree with 5–7 years of experience or Master's degree with 3–6 years of experience

Job description

Direct message the job poster from Advantage Technical

Technical Recruiter; - Recruiting with strong sense of urgency, honesty, integrity, and open communication.Offering direct hire roles and contract…

Job Title: Quality Engineer III

Schedule: Full-time, with some flexibility in start/end times (EST)

Job Overview

As a Quality Engineer III, you will play a key role in supporting quality initiatives in response to FDA findings. You’ll work onsite with a cross-functional team to develop, implement, and sustain quality engineering practices that meet internal and regulatory standards. This role focuses on quality assurance within a regulated medical device environment and includes both technical and leadership responsibilities.

Key Responsibilities

Lead or support departmental and cross-functional engineering initiatives related to quality and compliance.
Serve as a mentor and provide technical guidance to junior engineers and technicians.
Investigate, recommend, and implement best-in-class quality engineering practices.
Ensure effective process controls are in place to support development, qualification, and manufacturing.
Lead or contribute to the implementation of CAPA, process control, and assurance systems.
Use systematic problem-solving tools to identify, prioritize, and resolve quality issues.
Maintain compliance with internal procedures and external regulatory standards (FDA, ISO, etc.).
Support technical documentation efforts, including risk assessments, validations, and protocol development.
Promote visibility and communication around quality within functional, site, and corporate teams.

Qualifications

Bachelor’s degree with 5–7 years of experience, or Master’s degree with 3–6 years of experience.
Prior experience in the medical device industry is required.
Strong technical writing skills, with proven experience in authoring quality documentation and reports.
Detail-oriented and analytical thinker with a methodical approach to problem-solving.
Experience working with quality systems such as CAPA, NCR, validation, and process controls.
Familiarity with FDA regulatory standards and QSR (21 CFR Part 820).

Preferred Experience

Hands-on involvement with remediation projects or FDA audit responses.
Background in any of the following areas: Design Assurance, Supplier Quality, Operations Quality, Software Quality, Metrology, or Microbiology/Chemistry (depending on function).
Comfortable working in a fast-paced, collaborative team with cross-functional responsibilities.

Seniority level