Quality and Regulatory Compliance Manager

Who We Are

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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 Formerras Quality Management System across all aspects and functions of the organization within North America. Formerras Quality Manager is accountable for setting the long-range vision of quality and is the driver of quality improvement addition the role is responsible for managing regulatory compliance and maintaining the organizations ISO certification while leading a team comprised of quality and regulatory specialists.

Main Responsibilities

• Lead Formerras quality team; instill quality knowledge and process adherence and improvement throughout the organization.
• Perform on-going assessments of Formerras quality system effectiveness. Develop long-range vision based on identified performance gaps emerging customer requirements and external benchmarking. Formerras quality system includes corrective and preventive action internal auditing document control control of records process control cost of quality lab testing etc.
• Manage Formerras 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 Formerras 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:

Bachelors Degree in Business Engineering or related degree required.

Masters 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.
• Strong cultural awareness; able to work across the globe.

Required Length & Type of Experience:

• 3 -5 years in a quality or process improvement role.
• Minimum of five years experience in a manufacturing business. Cross functional experience highly preferred.

Preferred Certification Licenses Registration:

• ASQ Certified Quality Auditor
• ASQ Certified Manager of Quality/ Organization Excellence

PHYSICAL/ENVIRONMENTAL DEMANDS:

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.
• Typically work is in an office environment where the noise level is low to moderate but may occasionally occur in a manufacturing environment.

NOTE: The above stated duties are intended to outline those functions typically performed by individuals assigned to this classification. This description of duties is not intended to be all-inclusive or to limit the discretionary authority of supervisors to assign other tasks of similar nature or level of responsibility.

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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.
• NOTICE: Formerra is committed to ensuring a fair and legitimate recruitment process. We want to alert job applicants to the potential risk of recruitment scams and encourage caution when responding to unsolicited job postings or communications. If you receive a job offer without having explicitly applied through our website or a legitimate job board please be wary. We will never request sensitive personal informationsuch as your Social Security number birth date or banking detailsvia email. If you are uncertain about the legitimacy of a job posting or communication please contact us directly at.