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QA Compliance Specialist
| Details |
Country: USA
Location: MA Natick
Total applied: 14
Job Type: Employee
Job Status: Full Time
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QA Compliance Specialist
Job Description: ESSENTIAL DUTIES AND RESPONSIBILITIES
?Identifies quality system problems, while providing advice and solutions.
?Maintains an assessment system to audit local compliance in the Corporate Quality Manual, IC Procedures and local work instructions
?Assists in management of the document control for all procedures and quality records
?Ensures all the Procedures related to his/her function are in place and the appropriate personnel have been trained on them.
?Interacts with Cross Functional Team personnel in all quality related matters.
?Deals with Complaints and vigilance reporting and other related QA documentation, ensuring all required remedial steps are in place and documented.
?Utilizes all I-C communication tools
?Monitors and tracks Field Action reporting for all IC countries.
?Assist in the implementation and maintenance of ISO registration: including creating procedures, ensuring document controls, conducting training, maintaining training records and other related quality system activities as required
?Detail oriented
?Generates and provides reports on Inter-Continental Complaint and Field Action matrix.
?Data entry if Inter-Continental complaints
?Deveopment of complaint customer response letters.
REQUIREMENTS
? BS or BA degree
? Medical oriented studies a plus
? Communication skills
? Fluent in English (spoken & written)
? Able to operate MS Office
? Able to work independently
JOB PROFILE
?Manageability: Able to follow policies, accept external controls and supervision and work within the rules. Readily accepts authority and rules with a cooperative and friendly interpersonal style.
?Attitude: Has a positive attitude regarding people and outcomes. Demonstrates a highly positive attitude concerning risk, change and unexpected challenges.
?Accommodating: Is friendly, cooperative and agreeable. To be a team person. Promotes the benefits of teamwork and cooperation. Is usually willing to share resources and information.
?Influencing skills
?Project management skills: Is organized and methodical.
?Effective research & data analysis
Searchable Keywords: QA Compliance Specialist / gj-mo
Minimum Education Required: Bachelor
Years of Experience Required: Entry Level
Expected Travel Time: None
Boston Scientific offers incredible opportunities to grow and advance, a dynamic work environment and an excellent benefits package. Boston Scientific is an equal opportunity employer, M/F/D/V.
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