...equivalent combination of education and experience.
Prior experience in Medical Device or Pharmaceutical manufacturing support. FDA and ISO audit experience (13485, 21 CFR 820, 803, 806 and 14971) is preferred.
Strong, demonstrated ability to provide technically sound...
Suggested
Contract work
Flexible hours
...team of on-staff experts, and our efficient procurement websites. We are also proud to offer custom-configured computer systems from a ISO 9001:2015 certified technical configuration lab at our distribution center in Wilmington, OH.**
**Our company has over that ensure...
Suggested
Full time
Contract work
Work experience placement
Local area
Remote job
...30 pounds
Preferred Skills:
Experience operating Optical Comparator and CMM programs
Clean room experience
Knowledge of ISO and FDA regulations
Pay Details: $20.00 to $22.00 per hour
Benefit offerings available for our associates include...
Suggested
Hourly pay
Holiday work
Temporary work
For contractors
Local area
Afternoon shift
...specific technologies to applicable categories
~ Lean Manufacturing experience or Six Sigma experience
~ Willingness to travel 15 – 20%
ADDITIONAL QUALIFICATIONS
Knowledge of ISO Standards
PMI Certified
ISM Certified
~ Green Belt or Black Belt Certified...
Suggested
...in Java and one of the following: C, C++, or C#
~ Experience with medical device regulatory standards (21 CFR Part 820, IEC 62304, ISO 13485)
~ Understanding of revision control and issue tracking systems
~ Experience with software development life cycles (Agile, Spiral...
Suggested
Hourly pay
Holiday work
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For contractors
Local area
...practices).
# Ensure products are developed and released that meet customer expectations and regulatory requirements including 21CFR820, ISO 13485, and ISO 14971.
# Review and approve design verification and design validation documentation, risk management documentation,...
Suggested
Contract work
Flexible hours
...that include motion control interfaces
~ Experience with medical device regulatory guidance such as 21 CFR Part 820, IEC 62304 and ISO 13485 including experience with system risk / hazard analysis
~ Experience with software configuration tools for source code control...
Suggested
Local area
...instrument/software interfaces including motion control
Knowledge of medical device regulatory standards (21 CFR Part 820, IEC 62304, ISO 13485)
Experience with risk/hazard analysis within a regulated industry
Proficiency with configuration tools (CVS, SVN, Git),...
Suggested
Hourly pay
Holiday work
Temporary work
For contractors
Local area
...systems and issue tracking systems
Preferred Skills:
Knowledge of medical device regulatory standards (21 CFR Part 820, IEC 62304, ISO 13485)
Experience with system risk/hazard analysis
Proficiency with software configuration tools (CVS, SVN, Git), issue tracking...
Suggested
Hourly pay
Holiday work
Contract work
Temporary work
For contractors
Local area
Immediate start
...Experience in QMS/Regulatory
Must be US Citizenship or Permanent Residents due to ITAR regulations
Training Requirements
ISO Policy – Quality Policy
WI 4.2-5 – Good Documentation Practice
QP 7.6 – Control of Monitoring and Measuring Devices
WI 8.2-1...
Suggested
Permanent employment
Local area
Shift work
Afternoon shift
...ability to work effectively in a multi-discipline, collaborative environment
Experience in QMS/Regulatory
Training Requirements
ISO Policy – Quality Policy
WI 4.2-5 – Good Documentation Practice
QP 7.6 – Control of Monitoring and Measuring Devices
WI 8.2-1...
Suggested
Local area
Shift work
Afternoon shift
...Support the design review and phase gate process to ensure that engineering deliverables are at the appropriate level to meet FDA/ISO requirements & standards.
Accountable to oversee the development of requirements for different disciplines such as Software, Electrical...
Suggested
Flexible hours
...team of on-staff experts, and our efficient procurement websites. We are also proud to offer custom-configured computer systems from a ISO 9001:2015 certified technical configuration lab at our distribution center in Wilmington, OH. Our company has over 2,500 technical...
Suggested
Full time
Relocation bonus
Monday to Friday
...team of on-staff experts, and our efficient procurement websites. We are also proud to offer custom-configured computer systems from a ISO 9001:2015 certified technical configuration lab at our distribution center in Wilmington, OH. Our company has over 2,500 technical...
Suggested
Full time
Work experience placement
Local area
Shift work
...team of on-staff experts, and our efficient procurement websites. We are also proud to offer custom-configured computer systems from a ISO 9001:2015 certified technical configuration lab at our distribution center in Wilmington, OH. Our company has over 2,500 technical...
Suggested
Full time
...that include motion control interfaces
· Experience with medical device regulatory standards such as 21 CFR Part 820, IEC 62304 and ISO 13485 including experience with system risk / hazard analysis
· Experience with software configuration tools for source code...
Full time
Flexible hours
...have experience in an FDA regulated environment and have developed medical devices and/or instrumentation.
Should be familiar with ISO 13485.
Additional Information
Here Are Some of the Great Benefits We Offer:
Most locations offer a 9/80 schedule...
Full time
For contractors
Flexible hours
...team of on-staff experts, and our efficient procurement websites. We are also proud to offer custom-configured computer systems from a ISO 9001:2015 certified technical configuration lab at our distribution center in Wilmington, OH. Our company has over 2,500 technical...
Full time
Contract work
Local area
Immediate start
...Requirements
~ Bachelor's degree in engineering required.
~3+ years' experience with implementation, maintenance, and auditing of ISO 9001-2015 Quality System required.
~1+ year experience with communicating complex technical details and requirements with customers...
Temporary work
...Proficiency in SolidWorks or Autodesk Inventor.
Strong interpersonal and communication skills.
Excellent problem-solving abilities and multitasking skills.
Knowledge of ISO/AS9100 standards.
Interested in hearing more? Easy Apply now by clicking the "Apply" button.
...Ensure that all IT systems are compliant with Sequel Med Tech’s corporate directives, FDA regulations, Sarbanes Oxley regulations and ISO standards.
Inventory Management
Maintains IT asset lists and ensures that inventory levels are optimized.
Minimum...
Contract work
Local area
2 days per week
...quality requirements (i.e., MIL-STD-883, DFARs, AS9100, AS9102 First Article Inspection, DPA)
* Extensive experience and knowledge with ISO 9001
* Knowledge of Lean Manufacturing concepts including 5S
* Able to juggle multiple tasks and operate under deadlines, while...
Holiday work
Permanent employment
Local area
Flexible hours
Day shift
...quality control checks, quality control inspections and final product inspections.
* Responsible for ensuring compliance with AS9100 and ISO quality management system requirements.
* Acts as the Management Representative for all AS9100 and ISO issues.
Requirements:
*...
Work experience placement
...Experience using measurement devices (Calipers, micrometers, drop gauges, etc.)
* Applied working knowledge of Lean manufacturing, ISO Quality and DFSS principles- Green Belt Certification a plus.
* Must be a US Citizen or US Permanent Resident
Skills:
* Knowledge...
Permanent employment
For contractors
...needs in more than 120 countries worldwide. We use our expertise to produce to the highest standards, including ranges produced under ISO/IEC 17025 and accredited to ISO 17034. Our wide range of reference materials and proficiency testing schemes is complemented by our...
Worldwide
...writing
~ Preferred Skills:
~ Familiarity with IEC 60601 collateral and particular standards
~ Experience with Risk Management and ISO 14971
~ Proficiency in electrical circuit analysis with an understanding of transformers, insulation and power electronics
~...
Contract work
...quality product.
•Participates in scheduled team meetings and contributes to continuous improvement.
•Participates in maintaining ISO certification.
•Adheres to applicable System Level Procedures (SLPs).
•Emergency Action Warden: is responsible to be an Emergency...
Shift work
...Proficient in database management and with Microsoft Office Suite such as Word, Excel, and Outlook.
Preferred
Working knowledge of ISO/Aerospace standards.
Proficient in SolidWorks.
Working knowledge of various electrical equipment such as a DMM's,...
Holiday work
Full time
Part time
...standard requirements.
•Assist in audits (internal and external) by third party registrars and / or customers and maintaining the ISO 9001 and ISO 13485 procedures and work instructions.
•All other duties as assigned.
QUALIFICATIONS / EDUCATION / EXPERIENCE
•Bachelor...
Shift work
...Broad measurement instrument knowledge and experience with data analysis
Knowledge of FDA Quality System Regulations (QSRs) and/or ISO 13485 preferred
About DEKA:
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the...