Search Results: 227 vacancies
...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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...development through SQA function
Report on plant results according to the department indicators
Ensure the fulfillment of quality norms ISO IATF / TS 16949 and customer specifics requirements
Assure the completeness and archive of all relevant products/process data for...
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Local area
...Experience working within a quality management system; strong understanding of quality control systems and processes. Strong understanding of ISO 17025 preferred.
Technical Acumen: Strong understanding of particle analytical technologies and measurement system analysis...
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Work experience placement
Long distance
...com preferred
* Familiarity with regulatory requirements and quality standards applicable to medical devices (e.g., FDA regulations, ISO standards) a plus
Compensation: $75,000 - $90,000 annual base salary dependent upon experience
Please note that an application...
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Work experience placement
...functionality.
Forklift experience. (Certification will be required).
Overhead crane experience (Certification will be required).
ISO 14001 orientation / awareness training.
Yanfeng is a leading global automotive supplier, focusing on interior, exterior, seating,...
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Worldwide
...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...
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...accuracy, security, regulatory compliance and team awareness.
Assist with quality programs to maintain quality certifications. (I.e. ISO 9001/ISO 13485)
Knowledge & Skill Requirements:
Strong Computer skills are required for reports, charts, data analysis and...
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...-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...
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Temporary work
...~ Strong cross functional experience with Studio, Engineering, Suppliers and Quality
Bonus Qualifications
Familiarity with ISO GD&T Standards
Knowledge of CATIA V5, CATIA V6, and visualization software
Compensation
There are three major components to...
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Relocation bonus
...with a preference for cell and gene therapy products.
Profound knowledge of phase-appropriate cGMP regulations, including FDA, EMA, ISO standards, and ICH guidelines, especially as they relate to clinical programs.
Proven track record in regulatory compliance,...
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...and implementing cryptographic solutions for enterprise-level systems.Familiarity with security best practices and standards, such as ISO 27001, NIST, and FIPS.Programming skills in one or more programming languages such as C, C++, Java, or Python is a plus.Ability to...
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...ensuring that they are completed timely and properly documented.
* Provide site training and maintain a working knowledge of cGMP, ISO, and other relevant regulatory guidelines to act as a resource of information for site personnel.
* Ensure that Standard Operating...
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Worldwide
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..., per company guidelines.
* Coaches, trains, and develops team members.
* Additional duties as required.
Preferred Skills
* ISO 9001 Certified Auditor
* FMEA, Control Plan, APQP, PPAP knowledge
* 8D Problem Solving Methodology
* Lean/Six Sigma Green Belt...
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...device regulations and standards.
Ownership and manage the new product development processes, aligning with FDA Design Control and ISO 14971 Risk Management standards.
Drive and set reliability targets, testing, and validation activities align with company...
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Local area
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...techniques;
Work experience (at least 3 years) in quality assurance in comparable industry;
Comprehensive understanding of ISO 9000 family of standards;
Good developed stakeholder management skills and experience working with senior management, technical...
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Work experience placement
Weekend work
...preferably in engineering or other STEM-related field
At least 5 years of hands-on quality or regulatory experience in a U.S. FDA and ISO 13485 regulated environment
Experience with ISO 14971 and IEC 62304
Proven experience as quality representative on cross-...
Remote job
Flexible hours
...experience with quality tools including process flowcharts, FMEA's, control plans, CAPA, RCCA and 8D required
Experience working in an ISO 9001 certified environment required
Experience implementing Lean Manufacturing and Six Sigma methodologies including statistical...
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Permanent employment
Local area
...metrics, and their integration into the strategic and annual business plans.
Ensure that manufacturing is in compliance with FDA, GMP, ISO 13485, ISO 14971 and MDD requirements.
Perform other duties as assigned.
QUALIFICATIONS:
Bachelor's in a mechanical,...
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Local area
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...record all test data and maintain proper documentation of all lab work. Process customer returns in a timely manner in accordance with ISO and FDA QS Reg. Support company goal for timeliness of complaint investigations and closures. Knowledge of regulations and standards...
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...complaint handling process.
~ Previous experience with MDR Reporting via FDA portal.
~ Knowledge of FDA 21 CFR 820,21 CFR 803, and ISO 13485.
~ Experience working in the medical device industry, preferably Class III.
~ Strong communication and organizational...
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Local area
Work visa
Relocation package
Flexible hours
