Engineer II, QA

Thermo Fisher Scientific - Lenexa, KS

Full-time - Mid Level

Lenexa, KS

Computer and Electronic Product Manufacturing

About the position

As a Quality Assurance Specialist at Thermo Fisher Scientific Inc., you will play a vital role in ensuring that our products meet the highest standards and regulatory requirements. This position is critical for maintaining the integrity of our quality assurance processes, which are essential for competing in the global market. You will be part of an elite team dedicated to driving internal investigations, evaluating products, and reviewing processes to identify the root causes of quality issues. Your collaboration with multi-functional teams will be key in implementing corrective actions that ensure customer satisfaction and compliance with industry standards. In this role, you will implement and maintain procedures in strict compliance with 21 CFR Part 820 Quality System Regulations, ISO 13485 standards, and other applicable international standards. You will monitor and document various metrics, including complaint/product handling, stability testing, and performance, and present these findings to the Quality Review Board and other relevant parties. Testing products for microbial performance using ATCC organisms will be part of your responsibilities, along with preparing written responses to quality notifications or inquiries from customers, showcasing your exceptional written communication skills. You will lead issue review investigations to address concerns raised by customer complaints, ensuring that all issues are thoroughly addressed and resolved. Additionally, you will review quality documentation, such as device history records and processing records, to ensure compliance with internal policies and process requirements. As an expert within Thermo Fisher Scientific for complaint/product issues, you will provide guidance and support to colleagues across the organization and collaborate with customers and technical service representatives to effectively resolve any customer issues. Your participation in the development, maintenance, and monitoring of programs for compliance with the Quality Systems Regulations (QSR) and internal procedures will further enhance the quality assurance framework of the organization.

Responsibilities

• Drive internal investigations, including product evaluation and process review, to identify root cause of quality issues.
• Collaborate with multi-functional teams to efficiently implement corrective actions and ensure customer satisfaction.
• Implement and maintain procedures in strict compliance with 21 CFR Part 820 Quality System Regulations, ISO 13485 standards, and other applicable international standards.
• Monitor and document various metrics, including complaint/product handling, stability testing, and performance, and present them to the Quality Review Board and other relevant parties.
• Test products for microbial performance using ATCC organisms, providing timely and accurate responses to customer inquiries.
• Prepare written responses to quality notifications or inquiries from customers, demonstrating exceptional written communication skills.
• Lead issue review investigations to address concerns raised by customer complaints, ensuring that all issues are thoroughly addressed and resolved.
• Review quality documentation, such as device history records and processing records, to ensure compliance with internal policies and process requirements.
• Serve as an expert within Thermo Fisher Scientific for complaint/product issues, providing guidance and support to colleagues across the organization.
• Collaborate with customers and technical service representatives to effectively address and resolve any customer issues.
• Participate in development, maintenance, and monitoring of programs for compliance with the Quality Systems Regulations (QSR) and internal procedures.

Requirements

• Bachelor's of Science degree with experience in a laboratory setting required, preferably in Biology or Microbiology.
• 2 semesters or 1 year of experience in a laboratory setting.
• At least 2 years in a regulated environment such as medical device, pharmaceutical, biotechnology, clinical, or related field.
• Quality Control Microbiology laboratory experience preferred.
• Requires knowledge of Microsoft software programs.
• Strong understanding of quality-related tools, such as structured problem solving, data trending, and FMEA (Failure Mode and Effects Analysis).
• Ability to multitask, time management, and also be self-motivated.

Benefits

• Competitive remuneration
• Annual incentive plan bonus scheme
• Healthcare
• Range of employee benefits
• Outstanding career and development prospects
• Exciting company culture that stands for integrity, intensity, involvement, and innovation.