Validation & Calibration Engineer — Medical Device

LHH; Lincolnshire (IL); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Vacation time (2 weeks)

Paid sick leave where applicable by州

Medical Insurance

Dental Insurance

Vision Insurance

401K

Life Insurance

Job summary

LHH Recruitment Solutions has partnered with a growing medical device/pharma manufacturer seeking a Validation/Calibration Engineer to join their team. This role focuses on IQ/OQ/PQ validation, calibration management, and quality system support in a highly regulated environment.

You will collaborate with manufacturing, QA, engineering, and regulatory teams to ensure FDA/ISO compliance, maintain documentation, and support audits and CAPA activities, while delivering strong technical writing and

Qualifications

• Bachelor's Degree in Engineering or related technical discipline.
• 2+ years in QA, Validation, or Quality Systems in medical device/pharma.
• Experience writing/executing IQ, OQ, and PQ protocols.
• Knowledge of FDA quality system regulations (21 CFR Part 820) and ISO standards.
• Experience with QMS and electronic quality documentation platforms.
• Familiarity with calibration management and equipment tracking.
• Strong technical writing and analytical skills.
• Ability to manage multiple projects in a fast-paced environment.
• Experience supporting FDA inspections and regulatory audits.
• Exposure to DMR, design controls, and risk management.

Responsibilities

• Develop, execute, and maintain IQ/OQ/PQ validation documentation.
• Coordinate qualification activities for equipment, processes, utilities, and systems.
• Analyze validation data and prepare compliance reports.
• Collaborate with manufacturing, quality, engineering, and regulatory teams.
• Support change control and assess quality impacts of modifications.
• Maintain and improve quality system processes for regulatory compliance.
• Assist investigations, CAPA, nonconformances, and continuous improvement.
• Support documentation related to design controls and device history records.
• Contribute to audits, inspections, and quality system initiatives.
• Coordinate calibration schedules and track calibration program assets.

Skills

IQ/OQ/PQ protocols

FDA regulations knowledge

QMS experience

Calibration management

Technical writing

Project prioritization

GMP/cGMP knowledge

Regulatory audits

Risk management

Education

Bachelor's Degree in Engineering

Tools

QMS software platforms

Device Master Records (DMR)

Job description

LHH Recruitment Solutions has partnered with a growing medical device/pharma manufacturer seeking a Validation/Calibration Engineer to join their team. This role focuses on IQ/OQ/PQ validation, calibration management, and quality system support in a highly regulated environment.

You will collaborate with manufacturing, QA, engineering, and regulatory teams to ensure FDA/ISO compliance, maintain documentation, and support audits and CAPA activities, while delivering strong technical writing and