Product Surveillance Representative III

Job Description

Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results. All while wearing jeans to work!

Product Surveillance Representative III

YOU ARE more than just a title, YOU ARE...

• A Diligent Leader. You will manage the investigation, analysis, resolution, tending and corrective action of all complaints. Specific responsibilities include; maintain the compliant files and supporting the resolution of complaint CAPAs to closure and verification of CAPA effectiveness.

YOU WILL:

• Day-to-day review of service calls to identify and categorize complaints
• Establishes and maintains complete complaint files for all customer complaints
• Responsible for investigating complaints to resolve both product/procedure issues determined through failure analysis, focusing on root cause analysis
• Reviews and analyzes customer complaint information for trending/risk analysis and corrective action and resultant effectiveness of action
• Interfaces with customer service and technical service and other groups on a daily basis to drive timely completion of complaints
• May communicate directly with customer to resolve complaints
• Applies systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving complaints
• Maintains compliance to internal complaints procedure, FDA, ISO and Canadian medical device regulations

• Bachelor’s degree in science or other technical discipline or a minimum of 2 years relevant work experience preferred
• Minimum of 2 years of experience in FDA regulated medical device manufacturing environment(s) preferred
• Knowledge of QSR, ISO13485, and ISO14971
• Problem solver.
• Self-directed.
• Competent using office software including Database management, MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
• Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ALLERGAN complies.
• The employee is regularly required to lift and carry up to 10 pounds and occasionally lift and carry up to 25 pounds. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision.
• Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to analyze a variety of technical instructions in mathematical or diagram form and interpret various abstract and concrete variables. Ability to read technical and clinical literature and documents and extract important concepts.
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Ability to read, analyze, and interpret engineering specifications, general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, specifications, business correspondence, and procedure manuals in English. Ability to effectively present information and respond to questions from groups of managers, clients, and customers. Ability to clearly and concisely convey project accomplishments, obstacles, issues, and project status.

For this role, we’re looking for a leader who is:

• Excellence Focused
• Optimistic
• Open and Authentic

A Talent Magnet: The best leaders are brand ambassadors and have an eye out for great talent to join our family. All Allergan colleagues are an extension of our recruiting team, building bridges for the best people to grow our company.

At Allergan, we define the “Allergan edge,” as something that sets us apart, gives us an advantage and strengthens us to be better – for our customers, patients, investors and each other. Our 'edge' is our colleagues, and we are committed to making Allergan the best place for them to work and achieve career goals.

How do we do this? We Engage, Develop, and Reward our colleagues.

• Engage. F rom Day 1. You are a bold leader who wants to make an impact. We listen to your ideas and your questions, so we can be even better at what we do.
• Develop. Learn every day, build new skills every day. We prioritize development, so our leaders are always ready for the next challenge and opportunity.
• Reward. Exceptional performance creates exceptional opportunities and rewards. Financial awards and incentives are just a part of this - we invest in our people; celebrate successes through recognition programs; promote healthy lifestyles and work-life balance. We offer amazing benefits most of which start on your 1 ^st day at work (Medical, Dental, Vision, 401k – company match up to 8%, Tuition Reimbursement, and much more)