Quality Inspector

Quality Inspector

The Quality Inspector ensures that all components and finished medical products meet strict quality standards throughout the manufacturing and packaging process. This role performs incoming component inspections, in-line and in-process checks, issues labels, supports special inspection projects, and participates in AQL inspections when customer complaints arise. The inspector manages high-volume sampling for production lots and plays a key role in maintaining compliance with GMP, SOP, and FDA requirements while supporting a growing production operation.

Responsibilities

• Perform quality checks on medical products at all stages of the manufacturing and packaging process.
• Inspect incoming components and materials, including bottles, totes, caps, and other packaging, to identify defects or nonconformities.
• Conduct in-line and in-process inspections on the production floor to verify that products meet established quality standards.
• Handle inspection activities for special projects and participate in AQL inspections in response to customer complaints.
• Inspect and verify over 1,200 samples per production lot, ensuring accurate and consistent evaluation of product quality.
• Identify defects on packaging components and ensure that any nonconforming materials are flagged, documented, and addressed.
• Pull and issue labels from batch records for production personnel to apply to external packaging.
• Document all quality checks, inspections, and findings clearly and accurately in batch records and related quality documentation.
• Prepare and complete quality documentation such as NCRs, NCMRs, deviations, and batch record reviews.
• Ensure production personnel follow GMPs, SOPs, FDA regulations, and internal quality processes at all times.
• Support and monitor rework activities to ensure that reworked product meets quality standards before release.
• Work cross-functionally with production staff to resolve quality issues and support continuous improvement on the manufacturing floor.
• Communicate inspection results, quality concerns, and regulatory requirements clearly and professionally to production and other stakeholders.
• Assist with quality audits and line auditing activities to verify adherence to procedures and regulatory expectations.
• Maintain legible, accurate written records and ensure all documentation is completed in a timely and compliant manner.

Essential Skills

• Experience in quality control or quality inspection in a manufacturing environment.
• Hands-on experience with quality auditing and line auditing activities.
• Ability to perform batch record review and ensure documentation accuracy and completeness.
• Proficiency with labeling processes and handling labels for batch records and external packaging.
• Ability to prepare and manage quality documentation such as NCRs and deviations.
• Familiarity with GMP (Good Manufacturing Practices) in a production setting, with willingness to build on existing knowledge through training.
• Understanding of FDA-related quality expectations and inspections for regulated products.
• Computer literacy with the ability to write and update documents such as NCRs, NCMRs, and batch records.
• Strong verbal communication skills to clearly convey quality requirements and findings to production personnel and other teams.
• Legible and accurate handwriting for completing quality forms and batch records.
• Ability to work collaboratively and cross-functionally with production and other departments.
• Attention to detail and consistency when inspecting large sample sizes and documenting results.

Additional Skills & Qualifications

• High school diploma (HS Diploma).
• Experience with quality control for OTC drugs, cosmetics, or medical devices is beneficial.
• Experience with FDA-regulated environments and FDA inspections is an advantage.
• Understanding of federal regulations related to quality and manufacturing is a plus.
• Experience working with NCRs, NCMRs, deviations, and other quality system records.
• Experience in batch record review and documentation within a regulated production environment.
• Motivation to grow within a company and build a long-term career in quality.
• Reliability and strong attendance, including consistently arriving to work on time.

Work Environment

This role supports a manufacturing facility that produces OTC drugs, cosmetics, and medical devices, including products such as lubricating jellies, shampoos, and saline syringes. Training takes place on the first shift, after which the position transitions to second shift. Approximately 50% of the workday is spent on the production floor performing inspections and auditing activities, and 50% is spent in an office environment preparing and completing documentation and project-based quality work. The company is growing and adding multiple production lines, creating ongoing opportunities for advancement and internal career development. Paid holidays and prorated vacation time are provided, with PTO adjusted based on the hire date within the year. The culture emphasizes hard work, reliability, and internal growth, offering dedicated individuals a strong opportunity to build a long-term career in quality.

Job Type & Location

This is a Contract to Hire position based out of Hartland, WI.

Pay and Benefits

The pay range for this position is $20.00 - $21.00/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 Hartland, WI.

Application Deadline

This position is anticipated to close on Jun 12, 2026.