Publish With AIAA  •  Forms  •  Contact Us  •   View Cart   Search: 
Login
User Name:

Password:
Having trouble logging in?
Login help >

International Outreach



Aerospace America



Career Center

…an association alliance dedicated to advancing the industry and its engineering and science professionals. Click for more info.
Home  •  Industry News & Resources  •  Career Center
AIAA career center

  • For Job Seekers   
  • For Employers   
Home		  
  • Getting Started   
  • Create Professional Profile   
My Account		   Jobs      Bookmark and Share
  Browse Jobs  •  View All Jobs  •  Saved Jobs  •  Advanced Search Not Logged In [Log In]  

Job Detail 
Job Detail

Job Summary
Quality Assurance Complaint Analyst
Job Code: 10692BR 		POSTED: Nov 06
Salary: Open Location: Mahwah, New Jersey
Employer: Stryker Type: Full Time - Experienced
Category: Quality Required Education: 4 Year Degree



Employer Information
About Stryker

Stryker is an exceptional company with exceptional people who deliver exceptional results. We have differentiated ourselves by advancing meaningful innovations, creating cost-effective solutions for and improving the lives of our global customers and patients. As a winner of the 2007 and 2008 Gallup Great Workplace Award, we have demonstrated that Stryker has one of the most productive and engaged workforces in the world. Our exceptional results fuel ongoing opportunities for Stryker employees t....more info

View all our jobs


Job Description
Stryker is an exceptional company with exceptional people who deliver exceptional results. We have differentiated ourselves by advancing meaningful innovations, creating cost-effective solutions for and improving the lives of our global customers and patients. As a winner of the 2007 and 2008 Gallup Great Workplace Award, we have demonstrated that Stryker has one of the most productive and engaged workforces in the world.

Our exceptional results fuel ongoing opportunities for Stryker employees to build outstanding careers and to develop and grow both personally and professionally. Our work environment attracts many different kinds of talented and driven people who love to win and serve others. We always put quality first. We hold ourselves accountable to reach or exceed our goals and continually improve everything we do. These attributes are shared by the employees that make up Stryker. They are the things that bring us together and serve as the foundation of all we do. And they are the enablers of both our past and future success.

Stryker is one of the worlds leading medical technology companies with the most broadly based range of products in orthopaedics and a significant presence in other medical specialties. The Company's products include implants used in joint replacement, trauma, craniomaxillofacial and spinal surgeries; biologics; surgical, neurologic, ear, nose & throat and interventional pain equipment; endoscopic, surgical navigation, communications and digital imaging systems; as well as patient handling and emergency medical equipment. For more information about Stryker, please visit the company web site at: http://www.stryker.com.

Analyze product field complaints and perform root cause analyses leading to corrective action. Trend complaints for management reviews and work with design teams to improve the quality and reliability of the product. Coordinate product holds and regulatory action reporting.

Essential Duties & Responsibilities:

    • Create and initiate PER files transcribing faxed data into Complaint Database.
    • Monitor complaints for product trends and notify management of events requiring immediate action.
    • Follow up with Sales Reps and hospitals to obtain applicable information pertaining to reported events.
    • Obtain product function information in collaboration with engineers to determine reportability.
    • Review PERs for reportability to the FDA and other competent authorities under Medical Device Reporting and Medical Device Vigilance Regulations.
    • Ensure timely completion of MDR/MDV rationales and initial, supplemental, and final incident reports to FDA and other Competent Authorities within specified timeframes.
    • Monitor and trend MDR activity and prepare weekly status reports to management.
    • Mentor/lead less experienced analysts through the process of decision making.
    • Participate in continuous (breakthrough) improvement activity and process re-engineering projects in support of Stryker Orthopaedics' continuous improvement initiatives.
    • Continuously maintain, enhance and apply knowledge of applicable related federal and foreign regulations pertaining to Medical Device Reporting through training, reading, etc.
    • Perform training for in-house and field personnel on PER and MDR reporting.
    • Prepare ad-hoc reports of complaint and MDR trends.
Qualifications:

    • 3-5 years experience in the medical device industry analyzing product field complaints and performing root cause/corrective action analysis OR analyzing product complaints for reportability to the FDA and other Competent Authorities
    • Applied knowledge of regulatory requirements: 21 CFR, ISO 9001, Quality System Regulation and Medical Device Directive
    • Demonstrated project management skills
    • Demonstrated verbal, written and interpersonal skills
    • Demonstrated ability to work in a team environment; i.e., work closely with engineers and other team members in understanding device functionality and surgical techniques in evaluating complaints for reportability purposes
    • Demonstrated problem solving and troubleshooting skills
    • Demonstrated ability to approach work with positivity and energy, work effectively on a team, and advocate for product excellence and quality
    • Demonstrated results orientation with ability to effectively multi-task, learn quickly, respond to the urgent needs of the team; demonstrated long-term track record of delivering expected results on/before the agreed upon deadline
    • Literate in relevant personal computer applications with applied knowledge of Microsoft Office software
    • Applied knowledge of 21 CFR Part 806 and Regulatory Reporting requirements


    • Bachelor's Degree in Health or Sciences or other relevant field of study.



Stryker is an equal employment opportunity/affirmative action employer committed to hiring a diverse workforce. To read more about Stryker, please visit our website at www.stryker.jobs. Additional Information Reference Code:10692BR. Contact Information: Stryker www.stryker.com

To Apply for this position, please CLICK HERE

NOTES:
Additional Salary Information: Commensurate - Commensurate




We hope that these resources help with your job search or just staying marketable in your field of expertise.

The American Institute of Aeronautics and Astronautics (AIAA) is the world's largest technical society devoted to the global aerospace community.
Site Index•Copyright•Privacy Policy

© Copyright 2007 American Institute of Aeronautics and Astronautics, Inc.