Quality and Regulatory Compliance Manager

Formerra•Romeoville, IL

About The Position

Formerra is a preeminent distributor of engineered materials, connecting the world’s leading polymer producers with thousands of OEMs and brand owners across healthcare, consumer, industrial, and mobility markets. Powered by technical and commercial expertise, it brings a distinctive combination of portfolio depth, supply chain strength, industry knowledge, service, leading ecommerce capabilities, and ingenuity. The experienced Formerra team helps customers across multiple industries to design, select, process, and develop products in new and better ways – driving improved performance, productivity, reliability, and sustainability. To learn more, visit www.formerra.com. Formerra leads in the market with the following key capabilities: Problem-solving mindset, based on ingenuity and backed by a skilled and experienced commercial team that brings differentiated insights across markets including healthcare, consumer, industrial and mobility Expansive material portfolio, including engineering thermoplastics and traditional polymers across leading material brands Integrated, long-standing relationships with leading, global suppliers Unparalleled and highly specialized technical, processing, and design support Regulatory-compliant material support and expertise Position Objective Statement 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. Knowledge of ISO/TS 16949 and ISO 13485 is helpful
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.
Legal authorization to work in the US is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.

Nice To Haves

Master’s Degree: MBA preferred.
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.

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