JOB SUMMARY: The Quality Manager is responsible for maintaining and continuously improving the Quality Management System (QMS) to ensure compliance with current quality standards. This role oversees all Quality Assurance (QA) and Quality Control (QC) processes, including personnel supervision, internal auditing, quality improvement initiatives, regulatory compliance, and collaboration with customers and suppliers.
RESPONSIBILITIES
- Develop, implement, communicate, and maintain the quality plan to ensure compliance with applicable quality system requirements.
- Lead the implementation of resources and identify training needs within the QA function to support the QMS.
- Manage inspection and product release programs for incoming materials, in-process components, and finished goods.
- Establish and maintain quality objectives, policies, procedures, and QMS standards.
- Approve and facilitate customer-required validation activities.
- Promote quality performance and continuous improvement across the organization.
- Analyze performance metrics and KPIs to identify trends and improvement opportunities.
- Evaluate product specifications for both the company and its suppliers.
- Develop and maintain quality control systems and documentation procedures.
- Identify and coordinate quality-related training programs.
- Oversee and represent the QMS across the organization.
- Manage CAPAs (Corrective and Preventive Actions), NCRs (Non-Conformance Reports), and internal/external audits.
- Lead root cause analysis and drive corrective actions.
- Oversee site-wide calibration programs.
- Ensure compliance with ISO 9001 and ISO 13485 standards.
- Supervise, mentor, and develop the quality team.
- Create and maintain inspection plans.
EDUCATION AND EXPERIENCE REQUIREMENTS
- Bachelor's degree in Quality, Engineering, Manufacturing, or a related technical field (or equivalent experience).
- Minimum of 5 years of experience managing a certified Quality Management System (QMS), including at least 2 years in a leadership or supervisory role.
- Experience in a regulated manufacturing environment (plastic or metal machining)
- Lead auditor certified
- Hands-on experience with CAPA systems, audits, and root cause analysis methodologies.
SKILLS AND ABILITIES
- Strong leadership and team management skills.
- Excellent verbal and written communication abilities.
- Strong analytical and problem-solving skills with attention to detail.
- Ability to manage multiple priorities in a fast-paced environment.
- Proficiency in Microsoft Office Suite and quality or manufacturing software systems.
- Ability to work independently while collaborating effectively across departments.
- Strong commitment to safety and compliance
- Experience working with ERP/MRP systems in a manufacturing environment.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this position. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
