Location: Grand Rapids
Posted on: November 9, 2019
Position SummaryThe Quality Specialist is responsible for overall
Quality Management System compliance with FDA Quality System
Requirements, ISO 13485 standard and other applicable requirements.
This position implements, maintains, and improves systems to ensure
product meets defined quality requirements and customer
satisfaction is met.
Position QualificationsThe specific minimum competencies needed to
perform the essential duties of the job include knowledge, skills,
abilities, level of education, and experience necessary for
successful performance. These competencies are generally
demonstrated through specific service, education, or training.
Knowledge: -- Knowledge of quality standards for medical devices
(e.g. ISO 13485, FDA QSR, EU Medical Device Directives, and
Canadian Medical Device Regulations).
Skills & Abilities: -- Excellent verbal and written communication
skills. -- Excellent organizational skills and attention to detail.
-- Ability to multi-task.-- Sound, systematic problem solving
skills. -- Strong computer skills: MS Word, MS Excel (chart, pivot
tables), PowerPoint, database management and statistical
Level of Experience: -- A minimum of 4-6 years of Quality System
experience in an FDA regulated and/or ISO certified facility
(preferably ISO 13485).
Level of Education: Bachelor/Associates degree or equivalent work
Travel: Amount of travel availability required for
position.Occasional Overnight Travel Up to 10%
Essential Duties and Responsibilities
- Ensure all Quality System documentation is accurate and
- Initiate and update procedures, work instructions, forms,
specifications and other applicable documentation.
- Facilitate customer complaint activities throughout process to
ensure complaints thoroughly investigated and closed in a timely
- Drive timely execution of the CAPA process through initiation,
root cause investigation, corrective action plan, and verification
- Review and approve documentation: Changes initiated through
change control process, validation protocols and reports,
nonconforming dispositions, CAPA's and customer complaints.
- Support pre-and post audit activities and facilitate closure of
- Maintain and control the document data base (initiation,
approval, issuance and archiving).
- Assist in assembling and maintaining technical file
documentation to achieve CE Marking.
- Coordinate product samples with outside testing laboratories
such as: Biocompatibility, Accelerated Aging, and Transit.
- Identify, monitor and report on quality metrics.
- Develop and conduct training programs for personnel on Quality
- Identify areas of opportunity and support continual improvement
of the Quality Management System.
Keywords: SunMed, Grand Rapids , Quality Specialist, Other , Grand Rapids, Michigan
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