Quality Control Supervisor 2 yrs exp riq

Job Overview
We are seeking an experienced and detail-oriented Quality Control Supervisor to lead our quality assurance team within a manufacturing environment. The ideal candidate will oversee quality systems, ensure compliance with industry standards, and maintain the highest level of product quality. This role requires a strong understanding of ISO 13485, FDA regulations, HACCP, CGMP, ISO 9001, and other quality management frameworks. The supervisor will play a critical role in implementing quality audits, conducting inspections, and managing continuous improvement initiatives to uphold our commitment to excellence.

Duties

• Lead and coordinate quality control activities across manufacturing processes to ensure compliance with ISO 13485, FDA regulations, HACCP, CGMP, and ISO 9001 standards.
• Develop, implement, and maintain effective quality systems and procedures aligned with industry best practices.
• Conduct regular quality audits and inspections to identify areas for improvement and ensure adherence to regulatory requirements.
• Oversee quality inspection processes, ensuring products meet specified standards before release.
• Manage non-conformance issues by investigating root causes and implementing corrective and preventive actions (CAPA).
• Collaborate with cross-functional teams on projects related to product development, process improvements, and compliance initiatives.
• Provide training and mentorship to staff on quality assurance protocols and regulatory requirements.
• Prepare detailed reports on quality metrics, audit findings, and compliance status for management review.
• Support internal and external audits by regulatory agencies or clients.
• Maintain documentation related to quality management activities in accordance with industry standards.
• Initiate, draft, manage, and close CAPAs, deviations, non-conformances, and deficiencies.
• Maintain documentation related to compliance, non-compliance, and customer complaints.
• Ensure quality records, logs, and controlled documentation are accurate and audit ready.
• Support continuous operations and make proactive quality decisions on the manufacturing floor.
• Approve batches, tanks, and manufacturing lines prior to use.
• Authorize batch adjustments when products fall outside specifications.
• Approve line clearance and cleaning verification using swabs, conductivity, and other approved methods.
• Support water sampling and environmental monitoring activities.
• Review and approve Certificates of Analysis for raw materials, actives, and finished products.
• Review and certify analytical data.
• Prepare, support, and participate in internal, customer, and external audits.
• Perform monthly quality audits in Manufacturing and Operations.
• Lead, coordinate, and assign daily QC team tasks.
• Schedule and lead quality meetings and operational reviews.
• Train personnel on quality requirements, procedures, and packaging instructions.
• Coordinate QC activities with cross-functional departments.
• Support new processes, systems, customers, and regulatory requirements.
• Perform additional quality-related duties as required to support business needs.

Authority & Decision-Making

• Has the authority to stop production, place materials on hold, or escalate quality concerns when product quality, compliance, or safety may be compromised.

Qualifications

• Proven experience in manufacturing quality control or quality assurance roles within regulated industries such as medical devices or pharmaceuticals.
• Strong knowledge of ISO 13485, FDA regulations, HACCP, CGMP, ISO 9001 standards.
• Demonstrated expertise in conducting quality audits and inspections.
• Proficiency in developing and managing quality systems and documentation.
• Excellent analysis skills for root cause analysis and problem-solving.
• Project management skills with the ability to lead continuous improvement initiatives.
• Strong leadership capabilities with experience supervising QA/QC teams.
• Effective communication skills for training staff and reporting findings to senior management.
• Relevant certifications in Quality Management (e.g., CQE) are preferred but not mandatory. This position offers an opportunity to contribute significantly to maintaining the highest standards of product safety and quality while advancing your career within a dynamic manufacturing environment committed to excellence in quality management systems.

Pay: $ $28.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person