Global Complaints Manager - Medical Device Industry Job

Employer Name:	SpiderID: 2875352
Location: Braintree, Massachusetts	Date Posted: 9/2/2009
Wage: DOE	Category: Manufacturing
Job Code:
Number Of Openings: 1

Job Description:
Global Complaints Manager

Responsibilities:

• Responsible for compliance of facilities to requirements of FDA, applicable international regulations, and standards.
• Manages global customer complaint compliance including:
1. PIR documentation, investigation & response
2. Device defects investigation and response
3. Services issues investigation and support
4. Analysis of complaint trends and determination of corrective actions
5. Determination and notification of MDR/ADE (vigilance) events.
• Liaison between QS, Manufacturing, and R&D providing data analysis for global quality issues.
• Participates as a member of internal audit programs and Quality Systems controls.
• Provides management reports on effectiveness on CAPA, complaint, and product launch surveillance processes.

About Our Client:

For more than 30 years, our client has been a global leader in blood processing technology. Through its history, our client has earned a solid reputation for product innovation, technical expertise, and operational excellence. Today, our client’s products, internal R&D, marketing partnerships, and product acquisitions reflect the Company's unwavering commitment to provide safe and available blood for patient transfusions and for use in pharmaceuticals.

Our client is publicly traded on the New York Stock Exchange. They employ more than 1,800 people in 16 countries and market in over 50 countries.

Job Requirements:
Education:

• Bachelors degree required.

Required Experience

• 5 years of experience in Quality Assurance and Compliance for the design and production of medical products required.
• Exp. In operating successfully within an FDA regulated cGMP manufacturing facility is mandatory.

NOTE: This role requires travel 10-15% of the time. This includes international travel.

Job Criteria:
Start Date: ASAP
Position Type: Full-Time Permanent
Years of Experience Required: 5
Education Required: Bachelors
Overnight Travel: Less Than 25%
Vacation Time: Negotiable / Other

Company Profile:
Human Capital Consultants is a strategic professional services consulting organization serving industry leading, entrepreneurial, and near start-up organizations across the United States. Human Capital Consultants offers proven, customizable and matrix driven solutions for our clients’ Recruitment, Human Capital Management, and Human Resource Consulting needs. Human Capital Consultants has the experience and bandwidth to provide clients a wide array of resources from a single Recruitment or HR Resource to an entire team dedicated to single or multi-location needs, including Strategic Engagement Planning and Management. For more information visit our web site http://www.humancapitalconsultants.com.

Contact Information:

Contact Name: Mike Astringer	Company Type: Recruiter
Company: Human Captial Consultants	Phone: 800-378-0847
Street:	Fax:
City: Braintree
State: Massachusetts
Zip: 02184

Web Site: http://www.humancapitalconsultants.com