Engineer II, QA

Life Technologies - Lenexa, KS

Full-time - Entry Level

Lenexa, KS

Miscellaneous Manufacturing

About the position

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. In the role of Quality Assurance Specialist at Thermo Fisher Scientific Inc., you will have the unique opportunity to be a part of an elite team and contribute to the detailed execution of our quality assurance processes. This role is critical in ensuring that our products meet the highest standards and regulatory requirements, allowing us to compete in the global market. You will drive internal investigations, including product evaluation and process review, to identify the root cause of quality issues. Collaboration with multi-functional teams will be essential to efficiently implement corrective actions and ensure customer satisfaction. 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. Monitoring and documenting various metrics, including complaint/product handling, stability testing, and performance, will be part of your responsibilities, and you will present these metrics to the Quality Review Board and other relevant parties. Testing products for microbial performance using ATCC organisms and providing timely and accurate responses to customer inquiries will also be key aspects of your role. Additionally, you will prepare written responses to quality notifications or inquiries from customers, demonstrating exceptional written communication skills. Leading issue review investigations to address concerns raised by customer complaints will ensure that all issues are thoroughly addressed and resolved. You will review quality documentation, such as device history records and processing records, to ensure compliance with internal policies and process requirements. Serving as an expert within Thermo Fisher Scientific for complaint/product issues, you will provide guidance and support to colleagues across the organization. Collaborating with customers and technical service representatives will be essential to effectively address and resolve any customer issues. Finally, you will participate in the development, maintenance, and monitoring of programs for compliance with the Quality Systems Regulations (QSR) and internal procedures.

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.
• 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.