Job Overview

We are seeking a dedicated and detail-oriented Quality Manager to join our team. The ideal candidate will have a proven track record of designing, developing, and implementing comprehensive Quality Management Systems (QMS) from the ground up, ensuring compliance with industry standards such as ISO 9001. Adept at establishing and refining quality control procedures, conducting audits, and leading cross-functional teams to drive continuous improvement across manufacturing and operational processes. Possesses strong analytical skills, attention to detail, and the leadership necessary to foster a culture of quality throughout the organization, resulting in improved product reliability, customer satisfaction, and regulatory compliance. responsible for overseeing the quality assurance processes within our organization, ensuring that products meet both internal and external quality standards. This role requires a strong understanding of quality systems and compliance regulations, including CGMP, ISO 9001, and ISO 13485. The Quality Manager will play a crucial role in maintaining the integrity of our products through effective quality control and continuous improvement initiatives.

Responsibilities

• Develop, implement, and maintain quality assurance policies and procedures in accordance with ASME, CGMP, and ISO standards.
• Conduct regular quality inspections and audits to ensure compliance with established quality standards.
• Analyze data from quality control processes to identify trends and areas for improvement.
• Collaborate with cross-functional teams to address quality issues and implement corrective actions.
• Lead training programs for staff on quality assurance practices and procedures.
• Prepare detailed reports on quality metrics, audit findings, and improvement initiatives for management review.
• Stay updated on industry regulations and best practices related to quality management.

Skills

• Strong knowledge of CGMP, ISO 9001, ISO 13485, and other relevant quality standards.
• Proven experience in quality assurance, including conducting audits and inspections.
• Proficient in QA/QC methodologies and tools for effective quality control.
• Excellent analytical skills with the ability to interpret complex data sets.
• Strong attention to detail and organizational skills.
• Effective communication skills for collaboration with team members at all levels.
• Ability to lead projects focused on continuous improvement in quality systems.

Join us in our commitment to delivering high-quality products while fostering a culture of excellence within our organization.

Job Type: Full-time

Pay: $95,000.00 - $150,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Flexible schedule
• Health insurance
• Paid time off
• Professional development assistance
• Retirement plan

Schedule:

• 10 hour shift
• Day shift
• Overtime

Ability to Commute:

• Hamburg, NY 14075 (Required)

Ability to Relocate:

• Hamburg, NY 14075: Relocate before starting work (Preferred)

Work Location: In person