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45023557 Quality Systems Specialist - Mountain Lakes, NJ

Job Information

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# of Positions :
Minimum Education Level :
Experience Required :
2 years
Duration :
Full Time Regular
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Job Description


Quality Systems Specialist

Mountain Lakes, New Jersey

Location Mountain Lakes, New JerseyUS
Job ID JR-016826

EUROIMMUN US is a MDSAP registered, ISO 13485:2016, 21 CFR 820 compliant Medical device company that manufactures, distributes, and performs service and installation activities of in vitro diagnostic test kits and instruments used in the detection of autoimmune status, allergies, infectious diseases and antigen detection.
The incumbent for the position will be a valuable addition to the Quality Management department in leading the development of the organization's safety management system. The incumbent will provide training to other employees as necessary on the company's QM processes. The incumbent will play an active role in overseeing and contributing to assigned QM processes and participate in continuous improvement activities of the same. The incumbent will communicate actively and effectively with all departments and employees to support and ensure the requirements of the Quality Systems are met.
The Quality Systems Associate will report to the Quality Systems Manager.

Key Responsibilities:
Essential responsibilities include but are not limited to,

Adhere to all company policies, procedures and comply with all safety and regulatory requirements.

Assist in maintenance of the company's Quality Management System; maintains and demonstrates understanding of applicable regulations such as but not limited to ISO 13485, 21 CFR Part 820.

Takes lead role in development of company's Safety Management System in compliance with applicable regulations such as but not limited to 29 CFR 1910.

Takes lead role in managing QM training activities such as but not limited to organizing training events, preparing training materials, conducting training sessions, generating & maintaining training records.

Review technical and non-technical complaints for any CAPA, MDR, Adverse event activities are required periodically and close out complaints on time.

Participate in internal quality audits, prepare audit reports, initiate CAPA or other activities as necessary.

Monitor and measure metrics and present relevant data to the management.

Oversee and control processes for handling non-conforming products, returned products.

Perform investigations on non-conformances, provide suggestions for plan of correction.

Assist in preparing all necessary documentation required to ensure continuing compliance.

Other tasks, as assigned.

Basic Qualification:

Minimum of 2 years' experience in a regulated medical device or Pharmaceutical environment.

Experience in preparing materials, conducting training sessions and record keeping is preferred.

A minimum of Bachelor's in Life Sciences, Medical Technology or Science.

Preferred Qualification:

Strong understanding and experience with Quality Systems (medical device / clinical laboratory) is preferred.

Strong understanding of the OSHA's requirements on mitigating physical, chemical, and biological hazards is preferred.

Keen attention to details; ability to write SOPs and other technical documentation.

Deadline driven work ethic; ability to work with varying priorities.

Well-organized, ability to work efficiently and independently with minimum supervision.

Proactive, planning and exhibits high level of critical thinking abilities.

Strong verbal and written communication skills.

Enthusiastic demeanor with a can-do attitude.

Strong computer skills (MS Word, Excel, Outlook etc.).

PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

Company Information

Name :
Description :
PerkinElmer is a global leader focused on improving human and environmental health, for the better. We provide our customers with critical knowledge, expertise and innovative detection, imaging, software, and services solutions so that they can make better decisions for better outcomes. At PerkinElmer, we make a difference everyday helping scientists, clinicians and governments detect earlier and more accurately to improve the health and safety of people and the environment. Our solutions range from enabling the discovery of more effective diagnostics and therapies, to making sure that the food we eat, the water we drink, and our environment are safe from contaminants.
Type :
Direct Employer
Address :
80 Ruland Road

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