Senior Quality Assurance Specialist – Post Market Surveillance (PMS)
Are you a highly skilled and detail-oriented Quality Assurance Specialist with experience in post market surveillance? Are you looking for a new challenge in a dynamic and innovative company? Beckman Coulter is seeking a talented Senior Quality Assurance Specialist to join our team in ensuring the highest level of quality and compliance for our medical devices. If you have a strong background in PMS and a passion for improving patient outcomes, we want to hear from you. Join us in our mission to make a difference in the healthcare industry.
- Develop and implement quality assurance procedures for post market surveillance (PMS) in compliance with regulatory requirements.
- Conduct thorough and systematic reviews of PMS data to identify and address any potential product issues or safety concerns.
- Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to investigate and resolve any quality issues.
- Monitor and analyze PMS trends to identify areas for improvement and provide recommendations for corrective and preventive actions.
- Utilize statistical methods to analyze data and track performance metrics for PMS activities.
- Maintain and update PMS documentation, including standard operating procedures and work instructions.
- Participate in internal and external audits related to PMS and ensure compliance with relevant standards and regulations.
- Provide training and support to other team members on PMS processes and procedures.
- Stay current on industry regulations and guidelines related to PMS and ensure adherence to these requirements.
- Act as a subject matter expert and provide guidance to the organization on PMS best practices.
- Communicate PMS findings and recommendations to management and cross-functional teams.
- Continuously strive to improve the PMS process and contribute to the overall quality and safety of our medical devices.
- Represent the company in a professional manner and maintain a positive relationship with regulatory agencies and external stakeholders.
- Adhere to all company policies and procedures and maintain a high level of confidentiality with sensitive information.
- Embrace a culture of continuous improvement and actively participate in process improvement initiatives.
Extensive Knowledge Of Post-Market Surveillance Regulations And Quality System Requirements, Including Fda And Iso Standards.
Minimum Of 5 Years Of Experience In A Quality Assurance Role, With At Least 2 Years Specifically In Post-Market Surveillance.
Strong Analytical And Problem-Solving Skills, With The Ability To Identify And Address Potential Product Issues.
Excellent Communication And Interpersonal Skills, With The Ability To Collaborate With Cross-Functional Teams And Effectively Communicate Findings To Management.
Experience With Complaint Handling, Adverse Event Reporting, And Product Recalls, As Well As Conducting Risk Assessments And Implementing Corrective And Preventive Actions.
Risk Management
Quality Assurance
Project Management
Training
Data Analysis
statistical analysis
Auditing
Report Writing
Product Testing
Post Market Surveillance
Regulatory compliance
Problem-Solving
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
Interpersonal Skills
creativity
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Quality Assurance Specialist – Post Market Surveillance (PMS) in Clooncool, O'Callaghansmills, Co. Clare, Ireland is between €50,000 and €70,000 per year. This is an estimate based on salary data provided by job listings in the area. Actual salaries may vary depending on the specific responsibilities, experience level, and qualifications of the individual.
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Beckman Coulter Inc., is a Danaher Corporation company that develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing.
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