Quality and Regulatory Compliance Manager
13 days ago
Romeoville
Job Description 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 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 . 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 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., • 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. 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: Bachelors' 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 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., • 3 -5 years in a quality or process improvement role., • ASQ Certified Quality Auditor The characteristics listed below are representative of the physical and environmental demands required by an individual to successfully perform the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. • Requires sitting for prolonged periods of time, talking and listening., • Must be able to walk and use hands. Disclaimers: • 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., • The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job., • It is the policy of Formerra that all employees are employed at the will of Formerra for an indefinite period and are subject to termination at any time, for any reason, with or without cause or notice. At the same time, employees may terminate their employment at any time and for any reason., • Equal Opportunity Employer. All qualified candidates will receive consideration for employment and will not be discriminated against based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, pregnancy, genetic information, creed, citizenship status, marital status or any other consideration prohibited by law or contract.