Quality inspector

job summary:
Position Overview Providing 6-month coverage for a maternity leave, this role supports Quality Assurance and Manufacturing by reviewing Device History Records (DHRs), managing non-conformances, and ensuring full compliance with SOPs and medical device regulatory standards.

location: Sturtevant, Wisconsin
job type: Contract
work hours: 9 to 5
education: Associate


responsibilities:

• Documentation & DHR Release: Perform timely QA reviews of documentation for SOP compliance; conduct final reviews and execute release for finished Medical Device History Records (DHRs).
• Non-Conformance Handling: Identify compliance gaps during DHR review and initiate Non-Conformance Actions (NCAs).
• Quality Systems & Change Control: Assist with SOP creation/reviews and initiate change control processes.
• Product Certificates & Cross-Functional Support: Create/maintain Product Conformance Certificates for Merz North America; partner closely with Packaging and represent QA in cross-functional meetings.
• Metrics & Compliance: Maintain departmental reporting, metrics, and ensure team training records remain current.
• Operational Assistance: Assist with incoming inspections, product returns, training tasks, and continuous improvement projects across Manufacturing and Quality.

qualifications:

• Education & Experience: Bachelor's degree in a scientific, technical, or quality discipline (or equivalent experience) with 2+ years of QA experience in a regulated manufacturing environment.
• Medical Device & Regulatory Compliance: Strong understanding of FDA 21 CFR Part 820, ISO 13485, and general cGMP requirements.
• DHR & Documentation Review: Proven experience reviewing Medical Device History Records (DHRs) and executing final product releases.
• Non-Conformance Management: Direct experience identifying documentation errors, initiating Non-Conformance Actions (NCAs), and handling basic root-cause workflows.
• Quality Systems: Familiarity with change control processes and assisting with SOP authoring or revisions.

skills: Quality Assurance (QA), Quality Control (QC)


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 View email address on click.appcast.io.


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: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.