Sr. Quality Systems Administrator - (US-NJ-Mahwah)

Sr. Quality Systems Administrator - (US-NJ-Mahwah)

Compensation: $60K - $70K / Year
Minimum Education: Bachelors
Job Type: Full Time
Jobcode: S8397BRJA

If not you, would you know someone???  I will pay a finders' fee if you refer someone who is hired.

Experience Required : At least 1 year
Degree Required : 4 Year Degree
PAID RELOCATION AVAILABLE

Job Description Provide support to ensure the efficient operation of Quality Systems Administration processes including Device History Record Archiving, External Industry Standard Maintenance and Supplier change Notification

Divisional responsibility for computer systems configuration management and administration for systems such as ERP (Oracle) and Documentation Systems (Windchill). Provide technical oversight of systems Change Control activities. Additional responsibilities include change control management of procedural documentation and Engineering Change Notices (ECNs) through electronic systems. Ensure overall compliance with document control requirements and systems data integrity. Manage Lead and/or support activities for multifunctional process improvements and systems integration projects. Generate training materials associated with the systems and processes used in the department. Provide comprehensive formal instruction on system use at all SO locations. Provide technical support to system developers during implementation and validation of system modifications

ESSENTIAL DUTIES & RESPONSIBILITIES:

Manage and improve Divisional change control activities for QMS documentation, Drawing ECNs through integrated computer systems
Oversee Divisional processes for the ERP system and activities related to creation and maintenance of items (finished and non-finished goods)
Ensure overall compliance to data integrity as well as document and change control requirements
Manage activities for process improvements and Divisional systems integration as well as participate in continuous improvement activities and process re-engineering projects in support of Stryker Orthopaedics' Continuous Improvement initiatives
Deliver divisional training on systems and/or processes related to ECN, ECO, and documentation
Track, monitor and prepare divisional systems metrics for management review
Interact with personnel in US and international plants within all disciplines

Candidate Must Have :
* Knowledge of regulatory requirements: ISO 13485, Quality System Regulation 21 CFR 820 and Medical Device Directive
* Demonstrated technical understanding of electronic systems such as document management, ERP systems
* Demonstrated experience in item creation and maintenance activities in an electronic ERP (Oracle) system
* Bachelor’s Degree in Business, Information Technology or related science field

Email resume in Word to TheBigGameHunter@cisny.com. Please include the job code for the position with your resume.

NO VISA TRANSFERS. NO OVERSEAS RESUMES. NO 3RD PARTIES.

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