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...Job Description
Job Description **Position Description - Quality Assurance Manager - ISO**
**April 29, 2024**
**About Super Radiator Coils**
Super Radiator Coils is a leading engineering and manufacturing company in the niche market of custom commercial and industrial...
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...Job Description
Job Description Role As a Quality Assurance Manager (also known as ISO Program Leader, Quality Control Supervisor), you'll play a pivotal role in our company's growth. You will oversee our ISO program, which covers a wide range of custom commercial...
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...quality engineering experience in a plastic injection molding manufacturing environment.
~ Medical device industry experience including ISO 13485 & FDA CFR Part 820.
~ CMM/VCMM Programming.
~ Minitab experience helpful.
Minimum Education Requirements
~ Bachelor'...
Suggested
Shift work
...conformity.
4. Conducting root cause analysis of quality issues and implementing corrective actions.
5. Ensuring compliance with AS/ISO 9001 quality management system requirements.
6. Managing and maintaining document control systems, including process documentation...
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Permanent employment
...Job Description
Job Description REO Plastics, Inc. is a progressive, ISO certified Custom Injection Molding Company that have been in business for nearly 60 years serving several markets in the Manufacturing Industry. We believe in forging relationships with our customs...
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Holiday work
...prioritize, execute and report on projects
~ Ability to work on multiple tasks concurrently with changing priorities
~ Knowledge of ISO and FDA Quality System Requirements (e.g., ISO 13485; ISO 14969; IEC 62304; FDA 21 CFR Part 820)
Preferred:
~10+ years minimum...
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Contract work
Temporary work
Local area
Flexible hours
...and developing innovative solutions.
Experience with regulatory requirements and compliance in the biomedical industry (e.g., FDA, ISO).
Proven track record of successful project management, including the ability to prioritize tasks, meet deadlines, and adapt to...
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Holiday work
Temporary work
Flexible hours
...Technology (Highly Preferred)
~GD&T (Required)
~Experience producing tight tolerance parts is both production and prototype environments
~5+ years’ experience working in ISO or AS workplaces.
Interested in hearing more? Easy Apply now by clicking the "Apply" button.
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Hourly pay
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Part time
...Description:
The senior quality engineer position implements, maintains and enforces the internal quality management system to meet ISO standards and FDA quality system regulations. This position works closely with development and manufacturing to establish/ensure...
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Holiday work
...Regulatory Compliance:
Ensure compliance with regulatory requirements, industry standards, and customer specifications, including ISO, FDA, and other relevant regulations.
Prepare and maintain documentation for regulatory submissions, audits, and inspections, ensuring...
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Full time
Work experience placement
Remote job
Flexible hours
...policies and procedures.
+ Ensures audit readiness among all purchasing personnel.
+ Coordinates and conducts internal self-audits and ISO reviews.
+ Action audit findings to clear audit exposures.
**Knowledge/Skills/Competencies**
+ Basic knowledge of electronic...
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Night shift
...Control Plans, APQP, PPAP, and understanding of 8D (Ishikawa) root cause analysis, process and procedure creation.
Familiar with ISO 9000 requirements preferred
ASQ or Six Sigma Certification is preferred.
Experience working with ERP systems, SAP preferred. Able...
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...skills and ability to prioritize, execute and report on projects
~ Experience with Class III active implantables
~ Knowledge on ISO and FDA/Quality System Requirements. (e.g. ISO 13485; ISO 14969; FDA 21 CRF Part 820, 821, 822)
~ Strong project and time management...
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Part time
Local area
Flexible hours
...Biomedical) or related Science
~5+ years relevant experience within medical device industry or related function
~ Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance
~ Good statistical data analysis skills (...
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...environment.
It would be a plus if you also possess previous experience in:
~ Experience in a regulated industry preferred (e.g. FDS, ISO).
Physical Demands:
While performing the duties of this job, the associate is regularly required to stand for prolonged...
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...with creating project plans/schedules, & budgets
Preferred/Desired Qualifications
Understanding, execution and adherence to ISO 13485, CFR 21 Part 820, ISO 9001 and ISO 9001D
Professional certifications (PMP, SixSigma, EMS Program Management, etc.)...
Holiday work
Full time
Monday to Friday
...specifications. Our ideal candidate will have a basic working knowledge of Quality in a manufacturing setting, and be familiar with ISO 9001:2015 requirements. We are looking for an independent worker with excellent time management skills.
Responsibilities
Read,...
...primary Purchasing support for Flexible Packaging including all day to day purchasing activity
* Other duties as assigned
* Follows ISO SOPs as trained
**Secondary Tasks and Responsibilities (occupy balance of time)**
* Participates in quality improvement process...
Full time
Flexible hours
...preferred)
Knowledge of FDA Quality System Requirements and other applicable US Code of Federal Regulations for Devices. Knowledge of ISO 13485 standard. Knowledge of quality management techniques and application. Ability to clearly, concisely and accurately convey...
For contractors
Work experience placement
Shift work
...industry, ideally gained through internships or relevant positions, is advantageous
~ Prior experience working with 21 CFR 820 and ISO 13485, or ability to quickly learn
~ Strong critical technical thinking skills
~ Detail oriented, organized, and capable of working...
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