Vacancy expired!
Quality Control Analyst – Neenah, WIM-F 8am-5pm CSTRemote (possible travel to site as necessary)Pay- $42/hrJob Responsibilities:Execute assigned Post-Market Surveillance activities including Complaint Assessment, Reportability Determination, and Final Complaint Review primarily for low severity complaints. Flow to Work to assist other team members as needed.
Responsible for providing Post-Market Surveillance support for assigned mills/products. Responsible for completing Low Level Complaint Investigation records, as needed.
Executes continuous improvement plans and activities for established processes as assigned.
Maintains relationships with Consumer Services, including reporting of and troubleshooting errors, and coordinating complaint handling activities and improvements.
Builds and maintains capability for compliance with QMS, ISO, and FDA GMP's to support objectives.
Ensures activities and items are compliant with both company quality assurance standards and applicable government regulations, such as FDA 21CFR820-198, Canadian Medical Device Regulations SOR/98-282, and ISO requirements.
Maintain and demonstrate an appropriate level of knowledge and skill in quality systems, products, processes, and regulations.
Establish and maintain good customer rapport, while driving solutions to meet business needs. Develop and maintain a strong spirit of partnership.
Conduct all communications and transactions with the utmost integrity. Communicate fully with superiors, teammates, and others who have a need to know. Maintain compliance to K-C Code of Conduct.
Responsible for escalation of issues as they occur.
Assists with Quality Checks as needed/assigned.
Other tasks and special projects as assigned by management.
Maintain compliance by completing all required training in the required timeframes.
The primary customer base for this position is internal customers; however, the work done for the role impacts external customers as well.
Qualifications/Requirements:Requires a Bachelor’s degree in science, engineering or related discipline and/or 1+ years broad experience in a Quality, Manufacturing, Research & Engineering, or Regulatory function.
Demonstrates application of LEAN / Continuous Improvement skills.
Basic computer and software skills.
Good interpersonal skills.
Attention to detail.
Good oral and written communication skills.
Ability to work well in a team environment.
Ability to work independently with minimal daily instruction.
Ability to multitask and work in a fast-paced environment.
Knowledge of Medical Device, Consumer, Cosmetic, and/or Drug regulatory requirements is desired.
1-3 years customer service / complaint handling experience preferred
ETQ experience, and knowledge of FDA and Health Canada regulations highly desired.
You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.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 interests—it’s 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, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
