Quality, Safety & Compliance Specialist
About The Position
This role supports the plant's Safety, Health, Environmental, and Quality (SHEQ) programs. The specialist will be responsible for reviewing and verifying finished products to ensure they meet internal product specifications, customer requirements, and applicable quality standards. This includes conducting quality reviews of production records, certificates, and manufacturing documentation, as well as performing inspections of maintenance activities, source materials, equipment calibration programs, and process controls. The role also involves conducting routine safety, health, and compliance inspections throughout the facility, reporting non-conformances, and supporting corrective actions. Additionally, the specialist will assist with investigations related to deviations, non-conformances, customer complaints, and safety incidents, support product disposition activities, and track/trend quality and compliance metrics for continuous improvement. Training and guidance on quality systems, GMP requirements, and safety procedures will be provided, and the specialist will partner with operations leadership to foster a culture of safety, compliance, and operational excellence.
Requirements
- Bachelor’s or Associate’s degree in Science, Engineering, or a related technical field
- Knowledgeable in FDA regulations for medical products, specifically 21 CFR parts 210 and 211
- Strong communication skills
- Organizational agility
- Solid organizational skills
- Proficiency in Microsoft Office applications and Lotus Notes database
Nice To Haves
- Background in quality assurance for medical products
- Basic understanding of HTML and JavaScript
- Experience with ISO 9001, ISO 13485, or other regulatory standards
Responsibilities
- Supporting the plant's Safety, Health, Environmental, and Quality (SHEQ) programs
- Reviewing and verifying finished products meet internal product specifications, customer requirements, and applicable quality standards
- Conducting quality reviews of production records, certificates, and manufacturing documentation
- Performing inspections of maintenance activities, source materials, equipment calibration programs, and process controls
- Conducting routine safety, health, and compliance inspections throughout the facility
- Reporting quality, safety, and compliance non-conformances and supporting corrective actions
- Assisting with investigations involving deviations, non-conformances, customer complaints, and safety-related incidents
- Supporting product disposition activities, including product release and non-conforming product review
- Tracking and trending quality and compliance metrics to identify opportunities for continuous improvement
- Providing training and guidance on quality systems, GMP requirements, and safety procedures
- Partnering with operations leadership to promote a culture of safety, compliance, and operational excellence
Benefits
- Competitive compensation
- Outstanding benefits package
- Access to health, dental, disability, and life insurance
- Paid holidays and vacation
- Employee discount program
- Opportunities for educational and professional growth
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
