Quality Assurance Manager - Healthcare jobs in West Orange, NJ

We're looking for a Quality Control/Quality Assurance Manager who will play a pivotal role in ensuring quality standards in operations. You'll be the linchpin between manufacturing, engineering, supply chain, and design team, ensuring that our quality programs and systems are enforced. High attention to detail and a commitment to excellence are critical skills for this role.

You Will:

• Oversee the inspection of incoming materials and finished products, establishing criteria and procedures to maintain high-quality standards. Coordinate with suppliers to ensure compliance and train inspectors on proper techniques. Review inspection reports, follow up on corrective actions, and manage the product hold and release processes.
• Implement real-time tracking systems to monitor production operations, ensuring they meet quality standards. Identify and correct any process variances, and work with engineering to enhance manufacturing processes. Conduct regular audits and evaluate process performance to recommend necessary improvements.
• Develop and enforce compliance protocols to ensure adherence to regulatory standards and monitor quality policy compliance. Liaise with regulatory bodies to stay updated on quality requirements and conduct compliance training for team members. Keep quality assurance documentation current with regulatory changes.
• Lead and mentor the quality control staff, ensuring they are well-organized and fully staffed during production hours. Cultivate a culture of quality and precision within the team. Facilitate regular team meetings to address quality issues and drive resolutions, while also coordinating with other departments to tackle quality concerns appropriately.
• Analyze quality control data to pinpoint trends and improvement opportunities, and generate statistical reports on quality metrics. Utilize advanced data analysis tools to monitor product quality and process capability, providing actionable insights to cross-functional teams. Collaborate with IT to improve data collection and analysis systems, and establish data-driven decision-making within the quality department.
• Initiate and lead projects aimed at enhancing quality systems through continuous improvement. Facilitate cross-functional teams in problem-solving to optimize processes and monitor performance to identify further improvements. Engage with staff to support improvement activities and evaluate the efficiency of changes, making adjustments as necessary.
• Lead measurement system analysis to ensure the measuring equipment are giving accurate measurements.
• Manage and update control plans and other quality related documents on as needed basis.
• Submit detailed quality reports to the management team

You Have:

• Certification in Quality Management Systems (e.g., ISO 9001)
• 5 years in quality control or assurance management
• 3 years with statistical analysis tools and data-driven decision making
• Proficiency in quality inspection tools and methodologies
• Experience with real-time tracking systems for production monitoring
• Knowledge of regulatory compliance protocols in manufacturing
• Ability to develop and maintain quality assurance documentation
• Expertise in conducting audits and evaluating process performance
• Experience in leading quality improvement projects
• Knowledge with data analysis tools for quality control
• Experience with product hold and release processes
• Ability to liaise with suppliers for quality compliance
• Experience in training teams on compliance and inspection techniques
• Proven track record of improving product quality and process capability
• Successful implementation of quality management systems
• History of effective cross-functional team leadership in quality initiatives
• Demonstrated ability to assess and address quality-related issues
• Accomplished in enhancing manufacturing processes through quality control
• Recognized for maintaining high-quality standards in a manufacturing environment

Compensation Range:

$62k- $122k/ year
Your actual level and base salary will be determined on a case-by-case basis and may vary based on the following considerations: job-related knowledge and skills and experience.