Quality and Regulatory Compliance Manager

Formerra • Romeoville, IL

13h

About The Position

The Quality Manager has responsibility for Formerra’s Quality Management System across all aspects and functions of the organization within North America. Formerra’s Quality Manager is accountable for setting the long-range vision of quality and is the driver of quality improvement initiatives. In addition, the role is responsible for managing regulatory compliance and maintaining the organization’s ISO certification, while leading a team comprised of quality and regulatory specialists.

Requirements

• Bachelors’ Degree in Business, Engineering, or related degree required.
• Must be a consistent high performer with demonstrated leadership capabilities.
• Able to work in a team environment.
• Ability to coach and train others.
• Demonstrated analytical, verbal, and written communication skills.
• Ability to effectively present in front of senior leadership.
• This position requires strong computer and analytical skills combined with the ability to manage large amounts of quantitative data.
• Must have demonstrated mastery of quality tools and processes, especially within the framework of Lean Six Sigma (DMAIC and Lean).
• Expertise in ISO 9001 quality system standard.
• Solid business acumen and a background enabling a detailed understanding of multi-functional business issues.
• Strong cultural awareness; able to work across the globe.
• 3 -5 years in a quality or process improvement role.
• Minimum of five years’ experience in a manufacturing business.
• Cross functional experience highly preferred.

Nice To Haves

• MBA preferred.
• Knowledge of ISO/TS 16949 and ISO 13485 is helpful
• ASQ Certified Quality Auditor
• ASQ Certified Manager of Quality/ Organization Excellence

Responsibilities

• Lead Formerra’s quality team; instill quality knowledge, and process adherence and improvement throughout the organization.
• Perform on-going assessments of Formerra’s quality system effectiveness.
• Develop long-range vision based on identified performance gaps, emerging customer requirements and external benchmarking. Formerra’s quality system includes corrective and preventive action, internal auditing, document control, control of records, process control, cost of quality, lab testing, etc.
• Manage Formerra’s customer complaints and related processes. Determine acceptable level, severity, and close rate of customer complaints and drive desired results. Evaluate overall effectiveness and application by identifying trends and common issues; develop plans to address.
• Develop and maintain quality metrics, along with methods for the communication of results through executive dashboards and reports. Recommend and implement corrective actions where required.
• Define and implement root cause analysis processes, and enable assignment of financial responsibility to our material suppliers, logistics partners, or customers as appropriate.
• Manage Formerra’s central certifications (i.e. ISO) and related processes, and ensure all sites are meeting the standard.
• Evaluate and monitor (and participate as required in) all external customer quality audits to gather the collective voice of our customers and their needs. Coordinate investigation of evolving trends and related gaps and structure a plan to address.
• Interface with senior leaders by providing guidance on how to improve quality systems.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees