Engineer II, QA

Job Description

When you're part of Thermo Fisher Scientific, you'll do challenging work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With a mission to enable our customers to make the world healthier, cleaner and safer, we give our people the resources and chances to create significant contributions to the world.

Quality Assurance Specialist - Lenexa, KS

Position Summary:

The Quality Assurance Specialist is responsible for internal investigations including product evaluation, process review, and written communication to customers. Skills important to this position include; investigational process skills, including microbiological laboratory testing, coordination of cross-functional investigations, strong written and verbal communication skills. In addition, the Quality Assurance Specialist will implement procedures in compliance with 21 CFR Part 820 Quality System Regulations, ISO 13485 standards, and International standards that apply to various aspects of complaint/product handling, including evaluation and action associated with regulatory oversight.

What will you do?

Key Responsibilities:

• Responsible for the investigation and evaluation of customer complaints and logging of those complaints daily. The process includes investigation, monitoring, follow-up, and closure of all designated complaints/product issues. Specific activities include data entry and trending, cross-functional coordination and interaction to ensure a comprehensive investigation.
• Administer Quality unit functions including tracking and reporting metrics, Stability testing review and tracking, processing applicable Quality Notification investigations, coordinate and report investigations at corrective action team meetings, and Customer & FDA Advisories.
• Test products for microbial product performance using ATCC cultures in response to customer inquiries.
• Prepare written letters for customers following quality notifications or inquiries, including SCAR forms.
• Initiate and lead issue review investigations to address concerns identified as a result of customer quality notifications.
• Track and report metrics at Tier metric boards and at Quality review board meetings.
• Review device history records, processing records, and device master records for compliance with quality documentation policies and adherence to process requirements.
• Connect with customers and technical service representatives in both written and oral formats to ensure that communication of customer issues are adequately addressed.
• Serve as expert within Thermo Fisher Scientific for Complaint/Product issues.
• Serve as backup for technical literature (IFU, Labeling, etc.) reviews / approvals.
• Participate in development, maintenance, and monitoring of programs for compliance with the Quality Systems Regulations (QSR) and internal procedures.
• Perform other duties as assigned

How will you get here?

Minimum Requirements/Qualifications:

• Bachelor's Degree in a science or related field
• 2 semesters or 1 year of experience in a laboratory setting
• 1 year of experience in a regulated environment such as medical device, pharmaceutical, biotechnology or clinical
• Strong working knowledge of quality related tools, such as structured problem solving, data trending, and FMEA (Failure Mode and Effects Analysis).
• Experience using various software programs such as Excel, PowerPoint
• Ability to prioritize multiple tasks and function effectively.
• Demonstrated ability to work effectively as a member of a cross-functional team.

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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