quality/ validation manager.

We are seeking a Quality Validation Manager to join our team, responsible for ensuring the compliance of manufacturing equipment, processes, and sterilization protocols with industry regulations. This role involves developing, executing, and maintaining IQ/OQ/PQ validation protocols, with a focus on EtO (Ethylene Oxide) sterilization and adherence to ISO 11135, FDA 21 CFR Part 820, ISO 13485, and GMP standards. The ideal candidate will have experience in validation processes, risk management, and cross-functional collaboration to improve product quality and compliance.

salary: $95,000 - $105,000 per year
shift: First
work hours: 8 AM - 5 PM
education: Bachelors

Responsibilities

The Validation will be responsible for developing, executing, and maintaining IQ/OQ/PQ validation protocols for equipment, processes, and facilities. Key responsibilities include leading EtO sterilization validation efforts, ensuring compliance with ISO 11135, FDA 21 CFR Part 820, ISO 13485, and GMP regulations. The role involves conducting risk assessments, statistical analysis, and ensuring robust validation documentation in line with QMS requirements. The engineer will also collaborate with cross-functional teams to drive continuous improvement, validate new processes and equipment, and provide training on best practices. Additional duties include supporting other quality systems functions and staying current with industry trends.



The essential functions of this role include:

working in a smoke free environment

working up to 2 hrs of overtime per week

Skills

Quality Control (5 years of experience is required)

Validation Protocol (3 years of experience is required)

Sterilization Process (2 years of experience is required)

Risk Assessment (3 years of experience is required)

Statistical Analysis (3 years of experience is required)

QMS (5 years of experience is required)

Process Validation (2 years of experience is required)

Technical Writing

Project Management (2 years of experience is required)

CAPA (5 years of experience is required)

FDA (3 years of experience is required)

GMP (3 years of experience is required)

ISO 11135 (3 years of experience is required)

Qualifications

Years of experience: 2 years

Experience level: Experienced

Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad.

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.