SRGD5
Located in:
Grand Rapids, MI
Pay: $23-25/HR., based on experience
Job Full Description:
The Sr. Quality Technician supports the organization’s Quality Management System (QMS) by maintaining accurate documentation, investigating and processing nonconformances, assisting with complaint handling, and supporting Corrective and Preventive Actions (CAPA). This role ensures compliance with FDA, ISO 13485, and internal quality standards while driving continuous improvement across products and processes. The Quality Technician works closely with cross-functional teams to resolve quality issues, support audits, and uphold high standards of compliance and performance.
Responsibilities:
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Support complaint and CAPA investigations, using root cause analysis tools to identify failures and corrective actions.
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Create, update, and maintain quality trend analysis reports.
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Provide validation support for products, processes, packaging, and sterilization activities.
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Participate in pre-production planning meetings to ensure product requirements are clearly defined and within process capabilities.
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Support external and internal audit activities and monitor manufacturing processes for compliance.
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Assist in writing and reviewing specifications, inspection requirements, and work instructions.
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Liaise with suppliers to ensure compliance, manage corrective actions, and support supplier quality expectations.
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Execute document control processes, ensure training compliance, and support calibration and preventive maintenance programs.
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Provide training to personnel on quality processes, documentation, and compliance standards.
Schedule: Full-Time, Evaluation Hire
Job Experience
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Minimum of 3 years of quality control experience, preferably in a regulated industry.
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Working knowledge of FDA and ISO 13485 requirements strongly preferred.
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Strong understanding of quality improvement methodologies and CAPA systems.
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Excellent written and verbal communication skills; able to interface effectively with internal teams, customers, and suppliers.
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Highly organized and self-directed with the ability to manage multiple priorities.
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Proficient in root cause analysis, technical documentation, and problem-solving.
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Experience in validation, process improvement, or product development a plus.
Job Education
Bachelor’s degree in a related field required.
Grand Rapids, MI
Susan Delauter
Susan.Delauter@SRGexpress.com
616-608-9681
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