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Quality Assurance Manager
Sensors for Medicine and Science, a clinical
stage medical device company; seeks an experienced Quality
Assurance Manager with a take charge attitude and initiative
necessary to drive the Company’s quality efforts.
Job Functions:
- Implement and/or monitor programs
to promote quality consciousness among employees and
outside contractors, e.g. QSR training, quality teams,
design controls, production/process controls, quality
audits and "Good Manufacturing Practices"
(GMP) inspections.
- Monitor and supervise compliance of
outside contractors to established manufacturing methods
and procedures.
- Establish and/or implement parent company
product quality standards, specifications, parameters,
testing methods, design controls and manufacturing
methods.
- Render product clearance decisions
at different stages of the production process in order
to authorize continuation of production until eventual
release for sale or clinical trial.
- Assume full responsibility for batch
releases, approval of master documents, documentation
of quality investigations etc.
- Responsible for "QA-Validation"
activities, quality audits, and quality training to
ensure:
- Compliance with quality standards by suppliers
of materials and services
- Efficacy of testing methods
- Soundness of manufacturing practices
- Effectiveness of support systems (water purification
and climate controls)
- Efficient application of machinery, plant and
procedures in order to avoid mix-ups with materials,
packaging components and batch identifications
- Quality consciousness of all employees at the
site
- Analyze quality deviations and initiate
appropriate remedial actions, such as reworks, retests
and procedural improvements; or initiate product recalls
when products with critical quality defects are already
for sale on the market
- Communicate, through management reviews,
significant quality issues and corrective actions
to upper management.
Qualifications:
- B.S. in Engineering or related
technical field of study.
- Quality Engineering Certification (ASQ),
preferred.
- 5 - 10 Years experience in manufacturing
of Medical Devices
- Working knowledge of ISO 13485, Medical
Device Directive and FDA QSR/ GMP/GLP and CE mark
- Excellent documentation and computer
skills.
- Leadership and managerial qualities,
excellent communication and interpersonal skills
- Comfortable working under limited supervision
and direction.
- Able to prioritize work, multi-task
and work under deadline pressures.
We offer competitive salaries and benefits.
For consideration, please submit your resume electronically
to admin@s4ms.com
or fax to (301) 515-0988 or by mail to:
Sensors for Medicine and Science, Inc.
Attn: SJW0105
20451 Seneca Meadows Parkway
Germantown, MD 20876
Visit us at: http://www.s4ms.com/
Equal Opportunity Employer
Copyright
© 2011 Sensors for Medicine and Science, Inc.®
All rights reserved. Date of last update: 11/2/11.
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