Search Results: 14 vacancies
...accuracy.
Analyze proposed engineering changes for manufacturing impact and feasibility.
Participate in developing and maintaining ISO 9001 procedures and documents for the Process engineering department as required.
Assist Purchasing and Quality Assurance in...
Suggested
Local area
...Description
Working closely with the QA Manager, the QA Associate will be instrumental in ensuring site compliance with Regulations, ISO Standards, organizations SOPs as well as support in championing and developing organization's Quality Mindset, as well as a culture...
Suggested
Day shift
...and improvements as needed
Develop and maintain procedures to insuring quality relating to all production processes. Support of all ISO registrations
Resolves production issues in a timely manner
Assists other manufacturing engineers as needed
Assist design...
Suggested
Local area
Relocation
...Project experience preferred but not required
•ERP experience, preferred
Specialized Training:
•Knowledge of FDA regulations and/or ISO 13485 or similar ISO 9000 series training preferred but not required.
•Project Management training
Key Competencies:
•Ability...
Suggested
Work experience placement
Work from home
...Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
Support or serve as lead investigator for Exceptions to Standard Operating Procedures.
Generate or...
Suggested
Holiday work
For contractors
Outdoor
Shift work
...requirements.
•Experience with defect criteria based on PDA guidance.
•Experience with assembled auto-injector testing based on ISO requirements.
•Previous supervisory experience.
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built...
Suggested
Local area
...desirable:
Master’s degree in engineering, economics, or business.
Eight years of experience within any of the following areas: ISO/RTO Resource Adequacy, Generation interconnection or Transmission Planning, Utility resource planning, state regulatory engagement,...
Suggested
...systems
+ New product development, including APQP
+ Solidworks, AutoCAD, Creo, SQL
+ CNC machining
+ Quality Management Systems ISO-9001/TS-16949
+ High-volume manufacturing in electronic and/or mechanical manufacturing processes and assembly, including processes...
Suggested
...Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
Support or serve as lead investigator for Exceptions to Standard Operating Procedures.
Generate or...
Suggested
Contract work
...and vendor negotiations)
KNOWLEDGE/SKILLS/ABILITIES:
Knowledge of common information security management frameworks, such as ISO/IEC 27001, ITIL, COBIT as well as those from NIST, including 800-53 and Cybersecurity Framework
Demonstrated experience leading and...
Suggested
Holiday work
Contract work
...responsive to the laboratory mission to achieve
and maintain American Society for Crime Lab Directors (ASCLD)/LAB-International (ISO)
accreditation.
Plans and directs training, audit and consultative activities for evaluation of QA, quality control and
proficiency...
Suggested
Remote job
Full time
Contract work
Part time
Work experience placement
Local area
Relocation
Day shift
...Qualifications
Prior experience in Medical device and drug delivery devices
Knowledge of regulatory and standard guidelines such as: ISO 13485
Good understanding of the main process validation methodologies (process analysis for the best parameters identification...
Suggested
Full time
Contract work
Work visa
...solve problems.
~ Excellent problem-solving skills.
~ Good organizational and communication skills.
~ Familiarity with current ISO 9001 and ISO 27001 standards preferred.
~ Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
~ Basic understanding of CROs...
Suggested
...Calibration Coordinator for its Westfield Indiana location. This position will be responsible for supporting all calibration efforts using ISO 17025 accreditation guidelines. This includes tracking all items incoming and outgoing for calibration, reviewing, and approving...
Suggested
Hourly pay
Apprenticeship
Local area
