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Validation Engineer

Job Description

The Validation Engineer ensures the accuracy, reliability, and compliance of inspection methods used in the manufacturing of medical devices. This role involves validating automated inspection programs according to FDA, ISO, and ICH guidelines. Experience with automated optical inspection systems, including those integrated into Coordinate Measuring Machines (CMMs), is essential. Strong technical writing skills are required for developing validation protocols, test scripts, and reports.

Responsibilities

+ Develop and execute validation protocols (IQ, OQ, PQ) for inspection methods, ensuring compliance with FDA, ISO, and ICH guidelines.

+ Validate inspection programs for automated optical inspection systems, including CMMs.

+ Conduct risk assessments and define validation acceptance criteria based on statistical analysis and industry best practices.

+ Collaborate with Quality, Engineering, and Manufacturing teams to ensure inspection methods meet product and regulatory requirements.

+ Analyze and document validation results, authoring comprehensive reports and justifications for validation conclusions.

+ Maintain validation documentation to support audits and regulatory submissions.

+ Investigate validation-related nonconformances and recommend corrective actions as needed.

+ Stay up to date with industry regulations and best practices for validation of automated inspection systems.

Essential Skills

+ Engineering Degree

+ 3+ Years Equipment Validation Experience

+ IQ/OQ/PQ

+ Vision system, CMM and/or other inspection equipment validation

+ Test Method Validation

+ Technical Writing

Additional Skills & Qualifications

+ Experience with Minitab

+ Knowledge of Quality Inspection standards

Work Environment

This role requires onsite work. The company operates in two locations in Kendal, with one location in a high-rise building housing the Quality team, and the other in a two-story building with the doctor's surgery center on the first floor and the design team on the second floor. The company is a rapidly growing medical device manufacturer with around 100 employees, and their device assists individuals who are severely injured.

Pay and Benefits

The pay range for this position is $43.27 - $52.88/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Miami,FL.

Application Deadline

This position is anticipated to close on May 14, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.