Quality Assurance Specialist at Millipore Corporation in St. Louis, Missouri

Posted in Other 17 days ago.





Job Description:

Work Location: St. Louis, Missouri
Shift: No
Department: LS-SC-PMLQD Cell Marque Quality
Recruiter: Ashley Hennessy



This information is for internals only. Please do not share outside of the organization.




Your Role:



At MilliporeSigma, as the Quality Assurance Specialist you have responsibility for the Post Market Surveillance activities with our IVD products. This role will play a role in monitoring the safety and effectiveness our our IVD products after they have been marketed. The Post Market Surveillance Quality Assurance Specialist will be responsible for collecting and analyzing post market data, investigating field corrective actions, ensuring regulatory compliance and providing insight for continuous improvement of our products. The Quality Assurance Specialist will report directly to the St. Louis Cell Marque Quality Assurance Supervisor.


Key Responsibilities:


  • Monitor and analyze post market data from various sources, including customer feedback, complaints, field corrective actions and literature reviews.

  • Ensure compliance with post market surveillance regulations and contribute to the development and maintenance of post market surveillance plans, procedures and reports.

  • Collaborate with cross functional teams to assess the impact of field corrective actions, and support risk management activities, including root cause analysis and risk mitigation strategies.

  • Perform statistical analysis and trend analysis on post market data to identify potential improvements, safety concerns and market performance.

  • Support the development, implementation, and monitoring of Corrective and Preventive Action (CAPA) plans resulting from post market surveillance findings.

  • Prepare post market surveillance reports

  • Participate in customer and regulatory audits, as a Subject Matter Expert of applicable Quality Management System(s)




Who You Are:




Minimum Qualifications:

  • Bachelor's Degree in a scientific discipline (e.g., Biology, Chemistry, Microbiology, etc.) or a technical discipline (e.g., Computer Science, Data Science, etc. )




Preferred Qualifications:



  • Strong analytical, problem-solving and communication skills.

  • Proficiency in data analysis and trending techniques.

  • Strong understanding of risk managment and CAPA processes.

  • Ability to work autonomously, effectively manage time and deliver results on time.

  • Strong attention to detail and a commitment to quality and regulatory compliance.

RSREMD


The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
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