Icon hamburger
US
What job do you want?
Apply to this job.
Think you're the perfect candidate?
Apply Now
Thumsup

You’re being taken to an external site to apply.

Enter your email below to receive job recommendations for similar positions.
Mqc3fc6fnjh530y2r35

Complaint Specialist

Kelly Services Rochester Full-Time
$28,000.00 - $30,000.00 / year
Apply Now

Complaint Specialist Kelly Services has provided outstanding employment opportunities to the most talented professionals in the marketplace. Today, we are proud to offer an excellent contract opportunity for a Complaint Specialist,  with our client, a leader in the medical device industry, located in Rochester, New York. PURPOSE OF JOB: Primary responsibility is to support the global reporting obligations and the management of communication between manufacturer, distributors and competent authorities for all medical device complaint related activities, including assistance of and/or submission of medical device event reports in accordance with applicable local laws and regulations.  KEY ACTIVITIES/RESPONSIBILITIES Provide understanding, leading analysis and management of  information regarding medical device complaint events and/or adverse events, follow-up, case processing  and assessment  for post-marketing activities including:

  • Receives, documents and evaluates complaint information.
  • As required, communicates with physician, physician’s staff and/or patient to obtain pertinent complaint information.
  • Evaluates and engages appropriate management for critical and/or unusual events.
  • Liaises with internal functions (Quality, Regulatory, Medical Affairs, Customer Service, Manufacturing and R&D) to gather critical input into medical device event reports.
  • Reviews complaint manufacturing investigation reports and provides comments in accordance with procedures.
  • Performs and/or documents regulatory reportability decisions on complaints in accordance with applicable local laws regulations.
  • Ensures complaints are processed in a timely manner.
  • Reviews and closes complaint files.

Communicates with local and international competent authorities, including generation and/or submission of medical device event reports as required by applicable local laws and regulations. Assists local affiliates with the preparation and submission of medical device complaints and or incident reports, when required. Coordinates and prepares responses to competent authority inquiry’s associated with medical device report submission (Serious Injury and/or Device Malfunction). Participate in preparation for Notified Body audits and or Competent Authority inspections. When required, support root cause investigations and participates in CAPA (Corrective and Preventive Action) activities. Compiles case and process metrics. Supports complaint handling trending activities. Generates complaint data reports for other departments, when requested. As required, supports department projects and/or participates in cross functional projects. Generates periodic reports as requested per government agencies and/or Notified Bodies. SCOPE OF POSITION The scope of this position is directly related to global complaint management and adverse event reporting responsibilities for all company medical device products as assigned. The position will include interaction and communication with doctors and patients as well as internal business stakeholders.   QUALIFICATIONS/ TRAINING College degree required.  Scientific or business related discipline preferred (Engineering, Science, etc.). Knowledge of ophthalmic medical terms, Medical Device Reporting regulations, Vigilance Reporting regulations, GMPs for medical devices preferred. Position requires strong written, oral and listening communication skills in order to interact with customer and other professionals. Must be able to generate and organize clear, concise responses when communicating with various levels of management. Superior organizational skills to be able to manage challenging deadlines. Adjusts to change with minimum or no interruption. Recognizes problems and suggests applicable solutions. Able to perform job function with minor supervision and make independent decisions, where appropriate. Proficient in the use of personal computers, including database management, trending and word processing. Minimum of 3-5 years related work experience is required. important information: This position is recruited for by a remote Kelly office, not your local Kelly branch.  Applicants must be legally permitted to work in the United States. Why Kelly?

  • As a Kelly Services employee, you will have access to numerous perks, including:
  • Exposure to a variety of career opportunities as a result of our expansive network of client companies 
  • Career guides, information and tools to help you successfully position yourself throughout every stage of your career
  • Access to more than 3,000 online training courses through our Kelly Learning Center
  • Weekly pay and service bonus plans
  • Group-rate insurance options available immediately upon hire*

  Apply Today!



Why Kelly®?


At Kelly Services®, we work with the best. Our clients include 95 of the Fortune 100™ companies, and more than 70,000 hiring managers rely on Kelly annually to access the best talent to drive their business forward. If you only make one career connection today, connect with Kelly.



About Kelly Services®


As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit URL blocked - click to apply and connect with us on URL blocked - click to apply, URL blocked - click to apply and URL blocked - click to apply.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. URL blocked - click to apply

 

Recommended skills

Investigation
Auditing
Communication
Distributors
Manufacturing
Engineering

Location

Salary Details

Based on Job Title, Location and Skills
$29K
Below Avg. Average Above Avg.

Career Path

See the next step in your career
Complaint Specialist
$28,000.00 - $30,000.00 / year
Estimated Salary: $47K
Apply to this job.
Think you're the perfect candidate?
Apply Now

Help us improve CareerBuilder by providing feedback about this job: Report this job

Report this Job

Once a job has been reported, we will investigate it further. If you require a response, submit your question or concern to our Trust and Site Security Team

Job ID: US41ALJM_BH1590043

CAREERBUILDER TIP

For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.

By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.

It all began when William R. Kelly—founder of the temporary staffing industry—established Kelly Services® in 1946. The company's traditional expertise started with office services, call center, light industrial, and electronic assembly staffing. Through the years, we expanded our expertise and established a proven record of successfully matching job seekers to opportunities in disciplines such as science, engineering, law, education, healthcare, IT, and finance. As a Fortune 500® company, Kelly® has evolved into a global workforce solutions leader, making employment connections for nearly half a million people around the world every year. Since our founding, we have embodied the true spirit of social responsibility. Our character and values resonate through our culture. Inherently—through our core business focus—we seek to improve the quality of life for our employees, their families, and their communities, as well as society at large. We embrace the role we play and the value we contribute to society—whether ensuring equal opportunity to employment, promoting safer workplace conditions, advocating for healthcare reform, or adhering to sustainable business practices. Together with our employees and our customers, we will continue to work toward ensuring that our legacy will remain strong for generations to come. For more than 60 years, people have trusted Kelly Services to help them reach their career goals. We are your proven link to employment opportunities that will pave the way for a successful future. Whoever and wherever you are—and with the right skills and attitude—Kelly can help you find a job, expand your career, and build your future.

View the full profile