Quality Associate I

Location: 13900 Grandview Parkway, Sturtevant, WI (Onsite)

Job Type: Contract – 6 Months

Pay Rate: $24 per hour

Job Summary:

Merz Aesthetics 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 .

Key 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