What are the responsibilities and job description for the Quality/Regulatory - Specialist, Quality Assurance {Portage, MI} position at Matlen Silver?
Quality Assurance Specialist (Contract) Location: Portage, MI
Contract Length: 12 Months to Start
Experience Required: Minimum 3 Years
Education: Bachelor’s Degree Required
Position Overview We are seeking a detail-oriented and experienced Quality Assurance Specialist to support quality operations and compliance initiatives in a regulated environment. This individual contributor role requires sound professional judgment, the ability to work independently with minimal supervision, and a strong understanding of quality systems, regulatory compliance, and process improvement.
The ideal candidate will have hands-on experience implementing quality standards, supporting audits and inspections, and ensuring compliance throughout all stages of operational and production processes.
Key Responsibilities
Contract Length: 12 Months to Start
Experience Required: Minimum 3 Years
Education: Bachelor’s Degree Required
Position Overview We are seeking a detail-oriented and experienced Quality Assurance Specialist to support quality operations and compliance initiatives in a regulated environment. This individual contributor role requires sound professional judgment, the ability to work independently with minimal supervision, and a strong understanding of quality systems, regulatory compliance, and process improvement.
The ideal candidate will have hands-on experience implementing quality standards, supporting audits and inspections, and ensuring compliance throughout all stages of operational and production processes.
Key Responsibilities
- Implement and maintain quality standards across all stages of the process
- Ensure compliance with internal procedures, regulatory requirements, and quality systems
- Assess potential quality and compliance risks and provide recommendations for mitigation
- Take ownership of quality control activities related to:
- Laboratory studies
- Clinical research
- Testing and operations
- Raw materials
- Production processes
- Finished products and services
- Facilitate internal audits and regulatory inspections
- Coordinate and support quality training initiatives
- Apply professional expertise and independent judgment to resolve quality-related issues
- Collaborate cross-functionally to drive continuous improvement and compliance excellence
- Bachelor’s degree required
- Minimum of 3 years of relevant quality assurance or quality control experience
- Strong understanding of quality systems, compliance standards, and regulated environments
- Experience supporting audits and regulatory inspections
- Ability to work independently with minimal supervision
- Strong analytical, organizational, and communication skills
- Practical knowledge gained through hands-on industry experience preferred
- Experience in medical device, pharmaceutical, biotech, or healthcare environments
- Familiarity with GMP, GLP, GCP, FDA, or ISO standards
- Strong problem-solving and risk assessment capabilities