...Job Description
Job Description Immediate opportunity for two (2) Equipment Technicians to support an ISO 15189, 13485 and CAP / CLIA certified laboratory. As an Equipment Technician, you will be answering equipment issue tickets from the clinical laboratory, R&D and...
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Holiday work
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Immediate start
Shift work
Day shift
Afternoon shift
...EV
Identify and acquire quotes of test instruments and equipment required for new standards
Participate in audits (such as ISO 17025, CB) to maintain scope and accreditation of the test lab.
Review EMC reports including TCB
Who We're Looking For
~...
Suggested
Hourly pay
Worldwide
...and maintaining validated lines
Support overarching company goals, including but not limited to compliance with FDA regulations, ISO 13485, and any other applicable standards
Actively foster a positive working environment through clear communication, a solutions-...
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For contractors
...handling or adverse event reporting, in quality assurance, or similar role in the IVD or medical device industry
Working knowledge of ISO 13485, 21 CFR 820, ISO 14971, 21 CFR 803, 806, 812 and IVDR
PERSONAL TRAITS:
Project management skills
Reliable with high...
Suggested
Full time
Contract work
...assays, (2) Developing and validating new chemistry and/or process changes to enhance product performance, (3) Building out FDA/GMP/ISO compliant Scale-up, V&V, and tech transfer procedures, and (4) Serving as a mentor for junior engineers on the team. This role will enable...
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Flexible hours
...devices using breakthrough microfluidics, protein engineering, and data/cloud connectivity. AMDI will launch its first products from its ISO:13485 certified 110,000 square foot facility in Santa Ana, CA.
Summary of Position
We are seeking a highly motivated...
Suggested
Holiday work
Casual work
Local area
...audits of equipment records in our Asset Management System to confirm traceability and compliance with CLIA/CAP, FDA 21 CFR Part 820, and ISO 13485 / 15189 requirements.
Support routine service provider visits, internal and cross-functional investigations, and software /...
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Holiday work
Permanent employment
Contract work
Monday to Friday
....).
Knowledge of regulatory requirements and quality standards applicable to medical device manufacturing (e.g., FDA regulations, ISO standards).
Attention to detail and commitment to producing high-quality work while adhering to deadlines and priorities.
Effective...
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Work experience placement
Local area
...Experience:
Bachelor's degree in a technical field such as computer science, computer engineering or related field required.
Process certification, such as, Six Sigma, CBPP, BPM, ISO 20000, ITIL, CMMI. Report this job
Dice Id: 10211169d
Position Id: 8292636...
Suggested
Contract work
...such as computer science, computer engineering, or related field required.
Process certification, such as Six Sigma, CBPP, BPM, ISO 20000, ITIL, and CMMI.
Benefits:
~401(k).
~ Dental Insurance.
~ Health insurance.
~ Vision insurance.
~...
Suggested
Contract work
...EV
Identify and acquire quotes of test instruments and equipment required for new standards
Participate in audits (such as ISO 17025, CB) to maintain scope and accreditation of the test lab.
Review EMC reports including TCB
Who We're Looking For...
Suggested
Hourly pay
Part time
...systems in the Biotechnology industry.
In depth knowledge of regulations and guidance supporting GCP and GLP to include FDA, EMA, ISO standards and ICH guidelines with direct impact to clinical programs.
Experience reviewing and collaborating on regulatory submissions...
Suggested
Contract work
Apprenticeship
Local area
...real-world data (e.g., healthcare claims or electronic health records)
~ Knowledge of regulatory requirements (e.g. ICH, GCP, HIPAA, ISO) and a commitment to compliance
~ Experience authoring Standard Operating Procedures (SOPs) and similar documents in support of the...
Suggested
Full time
Flexible hours
2 days per week
...industry.
Prior experience in Quality performing inspections.
Competencies:
Attention to detail.
Knowledge of FDA, GMP, ISO 13485 regulations.
Knowledge of and prior experience using a range of measurement and test techniques such as optical measurement...
Suggested
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For contractors
...include the assessment of a supplier's quality management system using industry specific or general standards
Auditor Requirements:
ISO 9001 Certifications is a must.
Have relevant experience in environmental management.
Basic health and safety and social...
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Hourly pay
Contract work
For contractors
Worldwide
Shift work
...to clinical trial conductUnderstanding of appropriate global medical device/IVD requirements, such as: ICH E6 (GCP), European Union (ISO 20916, ISO 14155, IVDD/IVDR), US [21 CFR Part 812 and Part 11].
~ Experience managing GCP quality processes such as managing Quality...
Full time
Flexible hours
...the assessment of a supplier's quality management system using industry specific or general standards
Auditor Requirements:
ISO 9001 Certifications is a must.
Have relevant experience in environmental management.
Basic health and safety and social compliance...
Contract work
For contractors
Shift work
...knowledge of sheetmetal fabrication, machining, welding, painting, and electromechanical assembly preferred.
Working knowledge of ISO 9001 and ISO 13485
Previous experience with APQP, PPAP, MSA, PFMEA, Control Plans, etc. preferred.
Proficient in Microsoft Suite...
Contract work
...in Device physics, circuits/schematics, IC design, semiconductor fabrication and package manufacturing, etc.
Industry Standards: ISO, MIL-STD, AEC, JEDEC, IPC, etc.
Excellent written communication skills.
Must be a proficient communicator and listener.
Must...
Permanent employment
Local area
...orders strongly preferred
~ Shipping and handling experience in biotech or pharma industry preferred
~ Experience in an FDA, CLIA, ISO regulated industry, preferred
~ California Drivers License as Required
~ DG Certification preferred
~ Current/Prior forklift...
Hourly pay
Full time
Work from home
...Information Technology Services&##128197;Mar 20, 2024 Post Date&##128197;102610 Requisition # Stanford's Information Security Office (ISO) is looking for an experienced Senior Cybersecurity Architect with a diverse and deep cybersecurity technical background to work with...
Full time
Work experience placement
Remote job
...of experience with a Master’s Degree.
Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD and other applicable regulations.
Experience and understanding Process Validations (IQ, OQ, PQ), 6S, Lean Manufacturing
Experience...
Temporary work
...meet them
8.) Support Quality Management System
9.) Perform related work as assigned
10.) To maintain documentation following ISO
11.) To support engineer, technician and QC for QRQC action whenever issue occur
12.) Handle daily & weekly FPY & OBA report
13...
...Allen Wrenches
Keep parts in tolerance by changing offsets
Setup vertical or horizontal CNC mills
Experience working under ISO 9001
Education & Training/Experience:
~ High school diploma or equivalent
Please visit for more information or to submit your...
Contract work
Night shift
Day shift
Afternoon shift
...skills
Qualities We Look For
Experience with Medical Device Software and Hardware
Experience with QMS/eQMS
Knowledge of ISO 13485 / MDSAP
Global regulatory affairs experience (FDA, MDD/CE/MDR, UKCA, etc.)
Document Control experience
Proficiency in computer...
Holiday work
Casual work
Local area
H1b
...Skills and Experience
Experience with C#, Python, .NET WPF application.
Familiarity with databases (SQL, etc.)
Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment a plus.
Prior experience with complex device manufacturing is a plus....
Local area
...analog, and mechanical subsystems.
Recruit, train, organize, and retain the engineering development teams
Define and streamline the ISO-compliant Product Development Process
Software and hardware design assurance processes
Engineering implementation guidance...
Full time
Local area
Remote job
...Notable's comprehensive ISMS policy and procedure documentation
Assist with internal and external security audits (HITRUST, SOC 2, ISO, PCI)
Provide guidance to Notable teams to ensure compliance with the ISMS, address risk assessments
Assess external vendors for...
...-functional teams
Desired:
~ Experience in manufacturing in a regulated environment such as 14 CFR Part 21 , ISO9001, ISO 13485, TS16949, or equivalent
Compensation at Joby is a combination of base pay and Restricted Stock Units (RSUs). The target...
Temporary work
...have a good knowledge of lab supplies used at R&D.
Requirements :
Associates or Bachelor of Science Degree in Life Sciences.
Minimum 1-2 years laboratory experience in a BSL-2 laboratory.
Experience in a CAP/ CLIA/ GMP/ ISO regulated environment.
9403508
Shift work