Mid-level industry position
Requisition ID: 104865BRWhen you are part of the team at Thermo Fisher Scientific, you’ll do important work, bringing families together, reduce crime and supporting safer communities. Your work will have real-world impact, and you’ll be supported in achieving your career goals.Location/Division Specific InformationHow will you make an impact?Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $24 billion and approximately 70,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. Being part of HID you will have the ability to make your communities safe and allowing families to connect with their loved ones.What will you do?
- Performing raw material Quality Control physical Inspection of instrument and consumable parts, documentation, review test results, C of A review and raw material release.
- Maintaining accurate and complete records of inspection activities in compliance with ISO 9001, ISO 13485 and good documentation practices
- Assure compliance to internal SOPs
- Providing Quality oversight for issues of significant scope and complexity across multiple functional groups in order to ensure adherence to ISO standards.
- Creating problem reports/ NCMR’s and Deviations for nonconforming raw material
- Ensuring discrepancies are thoroughly identified, defined and properly assessed.
- Interacting with interdepartmental contacts on change and discrepancy assessment, resolution, and quality approval.
- Providing timely information to Operation.
- Update and meet metrics
- Revise procedures as needed.
- Maintain calibrated tools and equipment
- Be able to communicate technical issues and inspection results orally and in writing.
- Ability to work independently and as part of the IQC team
- Sense of urgency with completion of projects and tasks
- Serves as a backup for other Quality positions as needed
- Other duties and responsibilities as assigned
- Knowledge to interpret and inspect specifications per ANSI/Y14.5/ASME for mechanical parts, electrical parts such as PCAs, electrical units, electrical cables per IPC/MHMA-A-620, Class 2, to inspect and process C of A for chemical IQC
- Capable to use all precision inspection tools to perform test methods, equipment acquisition, sample plan definition, and validation development. Equipment includes calipers, micrometers, drop indicator, height gauge, comparator, CMM, Vision system, Keyence and pin gauge technique and other QC inspection tools.
- Convert units between English and metric systems (such as INCH to mm)
- Use various numbering methods, such as scientific notation, decimals, and fractions, and convert the values between these methods.
- May need to walk on a continuous basis, bend and lift to 40 lbs.
- Be able to read and interpret blueprints, SOPs and WINs and able to define critical, major, and minor characteristics.
How will you get here? Education: Experience
- Minimal of 2 to 5 years of hands on experience as quality control inspector in biotechnology or pharmaceutical desired.
- Demonstrated experience in a wide range of methods used in Engineering, instrumentation and tools used in Engineering related fields.
Knowledge, Skills, Abilities
- Experience with Agile and Track-Wise is preferred
- Proficient in data analysis and a working knowledge of SAP and excel is a plus.
- The candidate must have solid technical writing, interpersonal and communication skills and be a team player.
- Knowledge of International Standards ISO-9001, ISO-13485 and/or 21 Code of Federal Regulations (CFR) Part 820 Food and Drug Administration (FDA) Quality Systems Regulation (QSR) is a plus
This position does not have relocation assistanceAt Thermo Fisher Scientific, each one of our 70,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.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.
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.
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.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $24 billion and approximately 70,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands - Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services - we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.
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