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
- 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.
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.
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.
- 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
- 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
- Organizes the quality
management system and maintains its alignment to all regulatory and
- Interprets ISO and FDA
compliance standards and statutory requirements as they apply to the
- Researches compliance
requirements related to restricted and hazardous substances and end of
life disposal -
REACH, RoHS and IMDS etc.
- 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
- Ensures that documents are
authorized prior to release and that revisions and obsolete documents
- Responsible for managing and
routing controlled documents stored in the IQMS/ERP system, electronic
- 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
- 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
- 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
- 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.