Manufacturing _Quality Assurance Manager
3 weeks ago
Manufacturing
_Quality
Assurance
Manager _ Irwindale, CA 91706
Job Description
Salary 100k-120k Base
Title -
Manufacturing _Quality Assurance Manager
Job Description
Position Overview:
The Quality
Assurance Manager
of Manufacturing is responsible for leading and overseeing the quality assurance activities
within the company's medical device manufacturing operations . This role involves ensuring compliance with regulatory standards, maintaining product quality, and driving continuous improvement initiatives to enhance manufacturing processes.
Responsibilities:
Quality
Management
System (QMS)
Develop, implement, and maintain a robust and compliant quality
management system in accordance with FDA regulations (21 CFR Part 820) and ISO 13485 standards.
Monitor and enforce adherence to quality
policies, procedures, and work instructions across all manufacturing processes.
Regulatory Compliance
Stay current with FDA regulations and international medical device regulations to ensure the company's practices align with industry requirements.
Collaborate with regulatory affairs to prepare and submit regulatory documentation, including 510(k) submissions and other regulatory filings.
Product Quality
Assurance
Ensure that manufactured medical devices meet or exceed quality
standards, specifications, and performance requirements.
Implement robust inspection and testing processes to detect and prevent defects, deviations, and non-conformities.
Risk Management
Lead risk management
activities for the production, identifying potential risks associated with manufacturing processes and products.
Develop and execute risk mitigation strategies to minimize product-related risks.
Supplier Quality
Management
Collaborate with the procurement team to assess and qualify suppliers based on quality
and regulatory criteria.
Establish and maintain supplier quality
agreements, conduct audits, and manage supplier corrective actions.
Internal and External Audits
Plan and coordinate internal audits to assess the effectiveness of the QMS and manufacturing processes.
Participate in audits and inspections by regulatory authorities, addressing findings and implementing corrective and preventive actions (CAPAs).
Continuous Improvement
Drive a culture of continuous improvement by identifying process inefficiencies and opportunities for optimization.
Lead cross-functional teams to implement process enhancements and ensure sustained quality
improvement.
Document Control
Oversee the creation, review, and revision of manufacturing and quality -related documents, ensuring accuracy and compliance.
Maintain an organized and up-to-date document control system.
Ensure accurate and comprehensive documentation of quality
process, procedures, and production records.
Training and Development
Provide training and guidance to manufacturing personnel on quality
procedures, regulations, and best practices.
Foster a sense of ownership for quality
among all employees.
Metrics and Reporting
Develop and present quality
metrics and performance reports to senior management, highlighting key trends, achievements, and areas for improvement.
Qualifications:
Bachelor's degree in engineering, life sciences, or a related field; advanced degree preferred.
Significant experience (typically 5+ years) in quality
assurance within medical device manufacturing, with a strong understanding of FDA regulations and ISO 13485 standards.
Proven experience in leading quality
improvement initiatives and managing cross-functional teams.
Proficiency in risk management
methodologies and root cause analysis techniques.
Experience with internal and external audits, regulatory inspections, and interactions with regulatory agencies.
Detail-oriented mindset with a commitment to maintaining accurate records and documentation.
Proficiency in using quality
management software and tools.
Strong communication, leadership, and team-building skills.
Excellent problem-solving skills and the ability to make sound decisions under pressure.
Quality
management
certification (e.g., CQM, CMQ/OE) preferred
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