Quality Assurance Manager
4 days ago
Job Title: Quality Assurance Manager
Job Summary:
The Quality Assurance Manager is responsible for providing leadership and technical direction to production and engineering regarding quality compliance and process control. This role ensures that products meet customer requirements and processes continue to operate in accordance with company policies and procedures.
Key Responsibilities:
- Develop, implement, maintain, and continually improve a comprehensive quality management system (QMS) to ensure consistent product quality and compliance with regulatory and ISO standards.
- Establish quality standards for products and processes and suggest modifications to prevent defects in components and final products.
- Develop and initiate internal standards and processes for inspection, testing, and evaluation.
- Audit production processes to ensure established quality standards are met.
- Create and utilize risk mitigations tools, including process FMEA's, process control plans, and visual standards.
- Develop plant COQ (Cost of Quality) metrics and tracking methodology.
- Manage nonconformance, conduct root cause analysis, and coordinate implementation of corrective actions.
- Follow up to assure that corrective actions are in place and effective.
- Measure parts, complete process capability studies, conduct statistical process analysis, interpret results, and make recommendations regarding dimensional part tolerances.
- Develop and initiate quality control plans using engineering product drawings, process diagrams, and technical specifications to meet company requirements for ISO and customer requirements.
- Analyze quality data, identify problem areas, and assist in improving manufacturing processes and methods that affect quality.
- Participate in cross-functional product launch activities.
- Lead the APQP process and establish quality plans that manage potential risks.
- Apply continuous improvement methods to enhance manufacturing processes, quality, reliability, and/or cost effectiveness.
- Maintain professional working relations and effective communication with all team members, managers, vendors, customers, and regulatory agencies.
Regulatory Compliance:
The Quality Assurance Manager will lead regulatory (ISO: 13485:2016, FDA, and cGMP) and customer audits. Provide disposition of incoming, non-conforming materials in a timely manner and assure proper preventive actions are taken as needed.
Requirements:
The ideal candidate will have a strong background in quality management, regulatory compliance, and process control. A bachelor's degree in a related field and relevant work experience are required.
Why Work for MRA-THE MANAGEMENT ASSN INC:
MRA-THE MANAGEMENT ASSN INC is an Equal Opportunity/Affirmative Action Employer. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
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