Job Overview
We are seeking a highly skilled and detail-oriented Quality Assurance Manager to lead our testing and quality assurance efforts across various software applications and platforms. The ideal candidate will oversee testing processes, ensure product quality, and collaborate with development teams to implement best practices. This role requires strong technical expertise in software testing tools, programming languages, databases, and operating systems, along with excellent leadership and analytical skills. The position offers an opportunity to work on innovative projects within a dynamic environment focused on delivering high-quality solutions.
Duties:
1. Quality Management System (QMS) & Compliance
- Develop, implement, conduct, and maintain the Quality Management System, quality assurance programs, production, and inventory
- Develop and design quality modules, procedures, quality plans, for manufacturing processes and operations
- Ensure compliance with ISO standards, GMP, HACCP, EMS, safety, and customer requirements,
- Participate in Management Review meetings and provide quality performance updates.
- Serve as ISO, HACCP and GMP Coordinator.
- Maintain effective document control systems.
- Lead internal audits and coordinate external audits and certification activities.
2. Continuous Improvement & Operational Excellence
- Lead continuous improvement initiatives, including Agile-based improvement projects.
- Establish and monitor Quality KPIs and performance dashboards.
- Analyze quality trends and implement measurable improvement strategies.
- Promote a culture of quality and continuous improvement across departments.
3. Risk Management & Preventive Controls
- Serve as a member of the Risk Assessment Team, including FMEA (Failure Mode and Effects Analysis).
- Participate in safety hazard analysis and preventive risk mitigation planning, and develop and carry out safety plans and safety training programs.
- Identify quality and compliance risks and implement preventive controls.
4. Non-Conformance & Root Cause Analysis
- Oversee overall root cause analysis for major non-conformances and minor internal issues.
- Lead investigation processes using structured problem-solving methodologies.
- Ensure corrective and preventive measures address systemic issues effectively.
5. CAPA Management
- Lead the Corrective and Preventive Action (CAPA) program.
- Monitor CAPA implementation and completion timelines.
- Evaluate CAPA effectiveness and serve as final reviewer prior to Director approval.
- Ensure sustainability and verification of corrective actions.
6. Crisis Management & Recall Readiness
- Conduct crisis management reviews for significant quality incidents.
- Serve as a member of the Product Recall Team.
- Lead mock recall activities to ensure recall system effectiveness.
- Ensure recall readiness and compliance with regulatory requirements.
7. Quality Operations & Resource Management
- Ensure quality inspections are conducted in accordance with established standards.
- Supervise and evaluate quality inspectors.
- Lead recruitment, evaluation, and termination decisions for quality personnel.
- Ensure availability of appropriate quality inspection tools and equipment.
- Oversee calibration of quality tools and measuring instruments.
- Lead procurement of quality-related equipment.
- Manage departmental resources to support operational objectives.
8. Customer Quality & Stakeholder Coordination
- Coordinate with customers regarding quality matters and complaint resolution.
- Lead customer complaint investigations and corrective actions.
- Maintain strong customer quality relationships and compliance with contractual requirements.
9. Reporting & Accountability
- Prepare and present regular quality performance reports to the Operations Director.
- Collect and compile operational data and assist in the development of estimates, schedules, specifications and reports
- Provide management-level analysis of quality risks and compliance status.
- Accountable for overall product quality and regulatory compliance.
Accountability
- Overall quality of manufactured products.
- Product approval through validation and PPAP processes.
- Compliance with ISO, GMP, HACCP, EMS, safety, and customer requirements.
- Effectiveness of the QMS and CAPA system.
- Risk mitigation and recall preparedness.
- Performance and competency of the Quality team.
Requirements:
· Completion of a two- or three-year college program or higher, or equivalent, in a related field is required
· 2+ years of experience in a manufacturing quality assurance/inspection role is required
· Proven experience working with ERP systems such as IQMS and SAP in a manufacturing environment
· Certified ISO Lead Auditor with strong knowledge of quality management systems
· In-depth understanding of HACCP, GMP, Environmental Management Systems (EMS), and workplace safety standards
· Hands-on experience in process validation and Production Part Approval Process (PPAP)
· Strong knowledge of regulatory compliance and quality assurance practices in manufacturing
· In-depth knowledge of plastic production processes
· Strong leadership abilities
· Strong English communications skills (written and verbal)
· Basic computer skills with MS Word and Excel
· Skilled at multitasking and has strong organizational skills
· This is an on-site position; candidates are expected to work from our facility five days per week
Pay: $80,000.00 per year
Benefits:
- Casual dress
- Company events
- Dental care
- Extended health care
- On-site parking
- Paid time off
- Profit sharing
- Vision care
Work Location: In person
