11 days old

Remote Complaint Specialist - Post-Market Surveillance

Kelly Services
Neenah, WI 54956 Work Remotely
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Remote Complaint Specialist - Post-Market Surveillance** .

**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( ) however your resume must be received via the Submit Resume button included within.

**Job Title: Remote Complaint Specialist -** **Post-Market Surveillance**

**Pay: $28 per hour**

**Position Summary** :

Need resources who can process complaints including reviewing the complaint for accuracy, assigning complaint codes, assessing and documenting regulatory decisions (Medical devices, Cosmetics, and Consumer Products), completing complaint low level complaint investigations, and closing the complaint records. There will be times where the contractors will be asked to review follow up complaint information and document such information into the complaint records. Maintaining compliance, confidentiality of personal information, and data integrity is a must. Additional activities may be assigned specific to complaint management such as conducting retrospective reviews or compiling complaint data.

**Principal Responsibilities**

o Execute assigned Post-Market Surveillance activities, including Complaint Assessment, Investigation, Trending/Reporting, Final Review, and Sample Evaluation. Flow to Work to assist others as needed.

o Responsible for providing Post-Market Surveillance support to assigned Mills and/or Product Forms via Standard Work, data analysis, and communication. Responsible for completing Level 1 & 2 Complaint Investigations on behalf of Mills.

o Executes continuous improvement plans for the assigned sub-system(s) to deliver business results.

o Maintains relationships with Consumer Services, including reporting of and troubleshooting errors, and coordinating complaint handling activities and improvements.

o Builds and maintains capability within the assigned sub-system for compliance with QMS, ISO, and FDA GMP's.

o Ensures activities and items are in compliance with both company quality assurance standards and applicable government regulations, such as GMPs and ISO requirements.

o Maintain and demonstrate an appropriate level of knowledge and skill in product forms, quality systems, processes, and regulations.


o Typically requires a Bachelors degree in science, engineering or related discipline and/or 3+ years broad experience in a Quality, Manufacturing, Research & Engineering, or Regulatory function.

o Knowledge of Medical Device requirements is desired.

o Demonstrates application of LEAN/ Continuous Improvement skills.

**Skills** :

o Establish and maintain good customer rapport, while driving solutions to meet business needs. Develop and maintain a strong spirit of partnership.

o Conduct all communications and transactions with the utmost integrity. Communicate fully with superiors, teammates, and others who have a need to know.

o Executes continuous improvement activities for established processes and supports development of new processes.

o Builds and maintains capability in QMS, ISO, and GMPs to support objectives.

**Experience** :

ETQ experience would be great but not necessary.

Knowledge of FDA and Health Canada regulations would be great.

***Experience with Outlook, Word, Excel, and Power Point is required.


Hours: M-F 8am-5pm CST hours.

**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** at **.**

**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**

**Kelly Services is an Equal Opportunity Employer**

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-11-20 Expires: 2020-12-21

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Remote Complaint Specialist - Post-Market Surveillance

Kelly Services
Neenah, WI 54956

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