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Spec 4, Professional Services Project Mgmt
Ref No.: 18-02727
Location: Franklin Lakes, New Jersey
Position Type:Contract
Job Category:Management & Exec
Benefits:Medical Insurance
Hiring a Contract Project Manager 
Duration: 1 year Assignment 
Client Location:  Franklin Lakes, NJ
Work Schedule:  Monday - Friday / 40 Hours Weekly
Pay Rate:  $55 Hourly 

Core Responsibilities
•Consistent application of Quality system standards to assigned Quality system area
•Develops solutions to routine assigned activities of moderate scope & complexity
•Follows applicable Company / Unit procedures and may make updates to procedures and policies
•Works within and across functions for assigned Quality systems
•Expert Knowledge of Quality Systems Regulatory requirements and application to Company /Unit requirements
•Guides the successful completion of major programs and may function in a project leadership role

Position specific responsibilities include support of the following, however are not limited to:
•Supports and improves the Franklin Lakes and Quality System
•Collaborates with cross functional partners such as Quality Engineering, R&D, Operations, Medical, Marketing to seek their input into the development of policies and procedures, and their support in the development of harmonized quality system processes
•Develops training content and provides quality systems related training at unit and Plant locations
•Performs Internal and Supplier audits
•Participates in FDA, ISO, and other external audits. Ensures that pre and post-inspection activities are completed including scheduling, record review, training, logistics, etc.
•Analyze Quality Data and assist with Management Review content development

Education & Experience
•Requires a BS in a related scientific or engineering discipline and at least 8 years of experience in the Quality function of a Medical Device firm.

Knowledge & Skills
•Knowledge of US and International regulations and standards that apply to the medical device industry including FDA Quality Systems Regulations, ISO 13485, MDD, Canadian MDR, ANVISA, TGA, and PMDA.
•In-depth understanding of the application of quality systems to the medical device industry.
•Industry recognized certification in a Quality System element specialty (e.g. ASQ Certified Quality Auditor, Quality Engineer) preferred.
•Technical writing, auditing experience required.
•Prior experience managing external regulatory audits preferred.
•Excellent communication skills at all levels both written and verbal.
•Ability to perform multiple tasks and prioritize work load.
•Effective analytical, technical, and problem solving skills.
•Effective meeting and presentation skills.
•Self-motivated /directed.
To Apply for immediate consideration please send resume to Michael Estaris at and reference job #18-02727 in the Subject Line and indicate the best times to contact you (please include nights and weekends if needed).
**Candidates must complete background and drug screenings before starting any assignment.
On-Board Services provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.