Quality Inspector 2
Hologic, Inc. · Newark, DE · 2 wk ago
Full-time
About the role
We are seeking a Quality Control Inspector to ensure our products meet the highest standards of quality and compliance. In this role, you’ll perform inspections, testing, and sampling procedures for manufacturing processes and packaging lines. You’ll play a key part in maintaining compliance with FDA regulations, supporting investigations, and driving continuous improvement initiatives.
Responsibilities
- Perform inspections, testing, and sampling procedures for manufacturing processes and packaging lines.
- Maintain compliance with FDA regulations and medical device quality standards.
- Support non-conformance investigations and identify process improvements.
- Follow Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Maintain accurate, organized records and documentation.
- Participate in continuous improvement initiatives such as Kaizen events.
Requirements
- 2-4 years of experience in quality assurance or manufacturing roles, preferably in an FDA-regulated medical device environment.
- Hands-on experience with quality control tools and techniques.
- Familiarity with clean rooms, controlled environments, and production processes is a plus.
- Experience with Oracle ERRP or Agile Lifecycle Management System is beneficial.
- High School Diploma (H.S./GED) required; an Associate Degree is a plus.
Skills & Knowledge
- Familiarity with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Basic understanding of quality control tools and controls for nonconforming product.
- Knowledge of process auditing, documentation, and record-keeping.
- Ability to read and interpret operating procedures.
- Proficient in Microsoft Office applications, including Excel, Word, SharePoint, and OneDrive.
- Strong verbal and written communication skills for accurate documentation and collaboration.
- High attention to detail and focus on quality assurance processes.
- Analytical mindset for supporting investigations and driving improvements.
Behaviors
- Safety-conscious, maintaining a safe work environment and promptly addressing hazards.
- Proactive and dependable, with a strong sense of accountability for quality and timelines.
- Collaborative and team-oriented, fostering positive working relationships.
- Adaptable and eager to contribute to continuous improvement initiatives.
- Reliable and punctual, with a commitment to maintaining attendance and meeting deadlines.
Benefits
- Comprehensive training upon joining and continued development throughout your career.
Pay
The annualized base salary range for this role is $47,200 - $70,800 and is bonus eligible. Final compensation packages will depend on factors including relevant experience, skillset, knowledge, education, business needs, and market demand.