Our client is seeking a Quality Associate I to support quality investigations, documentation, and compliance activities within the company's Quality Management System (QMS). This role will assist in maintaining quality records, tracking corrective and preventive actions (CAPA), and ensuring compliance with regulatory requirements.
This is an entry-level or early-career quality role, ideal for candidates with a background in Quality Assurance, Engineering, or a regulated industry looking to gain hands-on experience in a medical device or pharmaceutical environment.
location: Sturtevant, Wisconsin
job type: Contract
salary: $20 - 24 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Assist with quality investigations by gathering data, reviewing records, and summarizing findings.
- Support CAPA documentation and tracking, ensuring all actions are recorded accurately and completed on time.
- Review and update quality documents, including standard operating procedures (SOPs) and reports.
- Prepare reports and summaries for audits, CAPA reviews, and regulatory inspections.
- Perform data entry and analysis related to quality trends, non-conformances, and process deviations.
- Collaborate with cross-functional teams to track and resolve quality-related issues.
- Ensure compliance with FDA, ISO 13485, and company quality policies through accurate documentation and record-keeping.
qualifications:
- Bachelor's degree in Physical Science, Engineering, or equivalent experience.
- Experience in Quality Assurance or a regulated industry (medical devices, pharmaceuticals, biotech, or manufacturing) preferred.
- Strong technical writing and problem-solving skills.
- Proficiency in Microsoft Office (Excel, Word, PowerPoint) and familiarity with QMS software.
- Attention to detail with strong organizational skills.
- Vision Assessment Required: 20/20 near visual acuity & acceptable color vision.
skills: Quality Assurance
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.
