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Quality Manager
Eldon James, Corp. -
Denver, CO

Manager, Quality & Regulatory Affairs

Eldon James manufacturers a wide range of plastic tubing, connectors and assemblies. We manufacture for life sciences, medical, automotive, food, beverage and chemical markets worldwide. This year we celebrate 27 years of success manufacturing the highest product quality and superior customer service to our valued customers. We are an ISO 9001-2008 and ISO 13485:2003 certified, woman owned company that thrives on quality, serving our customers and staying ahead of the curve with new innovations

Organizational Values

  • Aggressive Growth: Foster individual growth as contributing to company growth.
  • Dynamic Synergy: Aligning long-term employee and company goals for sustained success.
  • Exceptional Service: Delivering on all commitments, requirements, and expectations.
  • Tenacious Excellence: Daily focus on excellence in every area including product, process, relationships, and customer satisfaction.
  • Uncompromising Efficiency: Taking ownership to reduce waste and costs without compromising quality, excellence, and safety.
  • Effective Teamwork: We actively develop dynamic teams, realizing it takes effective relationships to accomplish our goals.
  • Positive Attitude: We value taking personal initiative to developing constructive solutions that impact continuous improvement.

Character Traits:

We are looking for a candidate that is flexible, dependable and self-confident. The ideal candidate for this position will need to be hands-on in a mentoring and training role. The candidate must also be detail-oriented. Being a supervisory position, patience and resilience under pressure is a must, as well as not being afraid of failure. Applicant will also need to display an attitude of excellence and be able to work in a team environment.

Position Summary and scope

The Manager, Quality & Regulatory Affairs position is responsible to the organization for maintaining the Quality Management System and ensuring compliance with regulatory standards and statutory requirements. This position fulfils the responsibilities of the organizationís Management Representative, representing the company in regulatory and customer audits, and promoting awareness of quality management system objectives and protocols at all levels of the organization. The Manager, Quality & Regulatory Affairs works with all departments in designing procedures compliant with ISO standards and customer expectations and serves as a customer liaison in addressing regulatory/compliance issues and corrective actions.

Organizational Relationships

The Manager, Quality & Regulatory Affairs leads the Quality Team and works closely with Top management, providing guidance on compliance and quality related issues. The position engages with all departments to author standard operating procedures and work instructions, problem solves quality system compliance issues; and promote awareness of quality system obligations. The Manager, Quality & Regulatory Affairs reports to the General Manager.

Responsibilities

  • Leads the Quality Unit to ensure that procedures affecting product quality are adequate. Works to ensure that customer expectations are being met and procedures are being followed
  • Leads the Quality Unit in initiating corrective actions when procedures are not followed and revises procedures when the procedures are deemed to be inadequate
  • Assumes the role of Lead Auditor, managing and organizing internal audits
  • Manages all improvement initiatives

Regulatory Compliance

  • Organizes the quality management system and maintains its alignment to all regulatory and ISO standards
  • Interprets ISO and FDA compliance standards and statutory requirements as they apply to the organization
  • Researches compliance requirements related to restricted and hazardous substances and end of life disposal -

REACH, RoHS and IMDS etc.

Technical Communications

  • Develops and makes revisions to Standard Operating Procedures and Work Instructions.
  • Maintains the organizations Quality Manuals: ISO 9001, ISO 13485
  • Provides documentation for customers to support technical and regulatory compliance
  • Responds to regulatory and customer audit findings and develops suitable corrective actions
  • Summarizes internal audit and management review meeting results
  • Develops well organized and understandable operational protocols, work instructions and training materials

Document Control

  • Ensures that documents are authorized prior to release and that revisions and obsolete documents are controlled
  • Responsible for managing and routing controlled documents stored in the IQMS/ERP system, electronic libraries
  • Responsible for maintaining and up-dating the Master Documents List and maintaining up-to-date, printed versions of Quality Manuals and Work Instructions based on revision control history

Experience, Education, Training and Expectations

  • Excellent oral and written communication skills.
  • Experience with administration of regulatory compliance in any of the following ISO 13485 or cGMP
  • Quality management / supervisory experience in a manufacturing environment a must, plastics preferred.
  • 4 year degree preferred or an associateís degree plus 10 years work experience in a relevant field.
  • Kaizen and Lean manufacturing experience a must.
  • Computer proficiency a must, and an ability to create and format sophisticated documents and forms is essential.
  • Experience in using ERP database systems for document control and data management is desirable.
  • An ability to learn and interpret technical regulatory and statutory requirements including ISO, FDA, cGMP, REACH, RoHS, USP, NSF, Animal Derivatives and environmental compliance is required.

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