Quality Engineer - Validation

EPM Scientific; Asheboro (NC); Hybrid; USD 65,000 - 85,000; Full time

Job summary

A leading medical device manufacturer in North Carolina is seeking a Validation Engineer for a contract position. This role involves applying quality engineering principles throughout the product lifecycle, ensuring compliance with standards, and managing validation activities. The successful candidate will work closely with cross-functional teams to enhance product quality and performance.

Qualifications

• Minimum of 3 years of experience in a similar role.
• Proficient in validation processes and statistical analysis.

Responsibilities

• Lead validation activities including protocol development and execution.
• Analyze process and product performance data.
• Collaborate with cross-functional teams to optimize manufacturing processes.

Skills

Analytical

Communication

Project Management

Education

Bachelor's degree in Engineering

Tools

Minitab

GD&T

Job description

Get AI-powered advice on this job and more exclusive features.

Direct message the job poster from EPM Scientific

Validation Engineer - Contract | Medical Device Manufacturer | North Carolina (Hybrid)

A leading medical device manufacturer in North Carolina is seeking a Validation Engineer for a contract position to support product development, validation, and quality assurance initiatives.

Position Summary:
This role applies quality engineering principles across all phases of the product lifecycle, including planning, development, and qualification/validation. The successful candidate will contribute to the deployment of quality strategies and ensure compliance with internal and external standards.

Key Responsibilities:

• Lead validation activities including protocol development and execution (IQ/OQ/PQ).
• Analyze process and product performance data to assess capability and compliance.
• Collaborate with cross-functional teams to optimize manufacturing processes.
• Develop validation documentation in accordance with internal and customer requirements.
• Manage multiple programs and customer deliverables simultaneously.

Qualifications:

• Bachelor's degree in Engineering or a related technical field.
• Minimum of 3 years of experience in a similar role, preferably in medical or pharmaceutical manufacturing.
• Proficient in validation processes and statistical analysis (Minitab preferred).
• Experience with plastic injection molding and GD&T (ASME Y14.5) is desirable.
• Strong analytical, communication, and project management skills.

Additional Skills:

• Knowledge of measurement system analysis (MSA/GR&R).
• Familiarity with quality assurance tools and time management practices.
• Ability to work independently and collaboratively in a fast-paced environment.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance and Engineering

• Industries

  Medical Equipment Manufacturing and Biotechnology Research

Referrals increase your chances of interviewing at EPM Scientific by 2x

Sign in to set job alerts for “Quality Engineer” roles.

Quality Engineer - ISO 9001, Metrology ($65K - $85K DOE)

Liberty, NC $65,000.00-$85,000.00 5 days ago

Manufacturing Engineer (Packaging Equipment)

Manufacturing Systems Engineer (THOMASVILLE, North Carolina, United States, 27360)

High Point, NC $70,000.00-$80,000.00 1 month ago

High Point, NC $115,000.00-$145,000.00 2 weeks ago

Assistant Project Manager (Electrical Construction)

Liberty, NC $95,000.00-$120,000.00 1 day ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.