Quality and Regulatory Compliance Manager

Quality and Regulatory Compliance Manager

Who We Are

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 e‑commerce 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.

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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.

Main 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.
< 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.

Minimum Qualifications

To perform this position successfully, an individual must be able to perform each job duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Required Education

Bachelor’s Degree in Business, Engineering, or related degree required.

Master’s Degree: MBA preferred.

Required Knowledge, Skills & Abilities

• 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…