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Job Summary:
The
Maintenance & Calibration Coordinator
will be part of Company's divisional
Maintenance and Calibration (M&C) team,
and contribute broadly to its M&C system
initiatives.Job
Description:
The
Maintenance & Calibration Coordinator will perform
all or some of the following Job
description:
-
Ensure external calibration
contractors complete work as
required, on time and using the
correct standard
-
Generate work orders for scheduled
equipment requirements, and ensure
activities are completed on time
-
Generate
metrics to trend unscheduled
equipment or tooling activities
Track
and trend calibration results
Identify, develop, and implement M&C
system enhancements and solutions
for continuous improvement
Initiate development and
implementation of M&C procedures;
modifying and updating SOPs as
needed
Work
with engineering, manufacturing, and
quality assurance teams to address
potential product concerns related
to maintenance, calibration, or
tooling issues; defining and
implementing effective corrective
actions; and monitoring
post-implementation effectiveness
Maintain and update equipment
records in accordance with quality
system requirements
Serve
as the primary M&C contact during
internal audits and external
inspections
Participate in identifying
system-critical components and
instruments
Prepare equipment for shipment when
external calibration activities are
required
Train
associates in M&C system
requirements
Enter
information into the calibration
database for machine records and
assign equipment numbers.
Minimum Requirements / Knowledge /
Skill For Maintenance & Calibration
Coordinator Job
-
1 year
experience in a maintenance and
calibration coordinator role in the
medical-device, pharmaceutical, or
similarly regulated industry
-
Sound
knowledge of M&C regulations, standards,
and guidance documents (21 CFR Part 820;
ISO 13485; NIST; Comprehensive
Dictionary of Measurement and Control,
2nd Ed.; Good Practice Guide to
Calibration Management; etc.)
-
Demonstrated knowledge of M&C software
systems
-
Project
management skills
-
Excellent
written and oral communication skills
-
Strong
interpersonal skills
-
Conflict
resolution skills
-
Ability
to work effectively in team situations
as well as independently
-
Ability
to influence and motivate others
-
Ability
to prioritize and multitask, setting and
meeting aggressive timelines
-
Basic
computer skills (e.g., MS Word, Excel,
PowerPoint, Visio, Lotus Notes)
-
Detail-oriented
-
Auditing
experience
-
Experience supporting FDA and/or
Notified Body inspections/audits
-
Leadership experience
-
Document
control and change management experience
and skills
-
Passionate
about coordinating M&C activities and
initiatives in support of state-of-the
art implantable medical devices
-
Be
energized by working for a world-class
manufacturer and collaborating on
cross-functional teams
-
Recognize
the importance of building and
maintaining strong interpersonal
relationships.
Minimum Education Requirements /
Certification / Licensure For
Maintenance & Calibration Coordinator Job
-
2-year
degree plus a minimum of 3 years
maintenance and calibration coordinator
experience, OR a minimum of 5 years
maintenance and calibration coordinator
experience in lieu of a degree
-
Bachelor's degree.
Find More Maintenance Job Descriptions Here
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