Global CAPA Engineer
4 weeks ago
*Preferred candidate able to commute daily to one of our sites located in Trevose, New Britain or Feastervill depending on the needs of the business*
Global CAPA Engineer
Position Summary
The CAPA Engineer is responsible for maintaining the Corrective and Preventive Action (CAPA) system to improve the quality of our products and processes at all OHCP sites.
Primary Responsibilities
•Direct activities to investigate, correct, prevent and verify the effectiveness of all CAPAs.
•Actively engage with process stakeholders to lead problem-solving activities and root cause analysis using industry standard methodologies, ie- flow chart, logic tree, fishbone, six sigma DMAIC model, A3, 5-Why, 8D, etc.
•Collaborate with process stakeholders to identify CAPA action plans that focus on prevention and mistake-proofing.
•Measure the effectiveness of CAPA action plans using objective data.
•Manage the CAPA records throughout all stages of process through closure.
•Evaluate priority of improvement opportunities based on resources available, impact on customers, impact on the business and cost.
•Identify opportunities to share solutions across sites as preventive action.
Basic Qualifications
Education
-Bachelor's degree, certification or equivalent in the Medical Packaging industry or Quality Assurance field.
-Five years related experience and/or training, preferably in a regulated industry such as food, medical device or pharmaceuticals.
Experience
-Strong knowledge of GMP and ISO 9001 or 13485 requirements.
-Stronganalytical skills, ability to analyze and interpret data using varioussoftware tools such as MS Office, MiniTab or related statistical software.
-Strong knowledge of industry standardroot cause investigation tools.
-Solidverbal and written communication skills.
-Strongorganizational skills and the ability to effectively manage time andmultitask.
-Abilityto write reports, business correspondence, and procedures.
-Read, analyze,and interpret SOPs and Regulatory Standards.
-Abilityto bring team members from multiple departments and with differentperspectives and goals to become effective CAPA investigation teammembers.
-
Global Supplier Quality Manager
1 week ago
Fort Washington, United States Oliver Healthcare Packaging Full timeGlobal Supplier Quality ManagerPosition SummaryThis position works with suppliers to resolve specific quality issues and provide quality control expertise. The role involves facilitating corrective actions with suppliers, monitoring their CAPA investigations, and ensuring effectiveness of corrective actions taken.This role also facilitates supplier audits...
-
Global Supplier Quality Manager
1 week ago
Fort Washington, United States Oliver Healthcare Packaging Full timeGlobal Supplier Quality Manager Position Summary This position works with suppliers to resolve specific quality issues and provide quality control expertise. The role involves facilitating corrective actions with suppliers, monitoring their CAPA investigations, and ensuring effectiveness of corrective actions taken.This role also facilitates supplier audits...
-
Global Supplier Quality Manager
2 days ago
Fort Washington, United States Oliver Healthcare Packaging Full timeGlobal Supplier Quality Manager Position Summary This position works with suppliers to resolve specific quality issues and provide quality control expertise. The role involves facilitating corrective actions with suppliers, monitoring their CAPA investigations, and ensuring effectiveness of corrective actions taken.This role also facilitates supplier audits...
-
Quality Engineer
4 weeks ago
Fort Washington, United States Insight Global Full timeMust Haves: 3+ years experience in a quality related role in a manufacturing environment Strong root cause analysis (i.e. Flow charts, fishbone, six sigma, 5-Why, 8D, DMAIC) Strong knowledge and understanding of ISO standards (ISO 13485 is preferred) Experience leading CAPAs (Corrective And Preventative Action) or Audits Very Detail oriented and organized...
-
HCG Quality Engineer
1 month ago
Washington, United States Horizon Controls Group Full timeJob DescriptionAs the Quality Engineer, you are responsible for product quality assurance and quality engineering. You will provide technical oversight and maintain quality systems that are effective and comply with federal, state, local, and other applicable international regulations, and standards. You will also ensure compliance with site policies and...
-
Capital Project Manager
4 days ago
Fort Washington, United States Insight Global Full timeJob Title: Project Manager Duration: 1.5-2 year long contract Location: Fort Washington, PA Required Skills and Experience: Experience managing capital project ($10-20MM budget) Excellent written and oral communication skills Bachelor's Degree in Engineering, Scientific, or Mathematical related field 5+ years of Project Management experience Nice to Have...
-
Capital Project Manager
1 day ago
Fort Washington, United States Insight Global Full timeJob Title: Project Manager Duration: 1.5-2 year long contract Location: Fort Washington, PA Required Skills and Experience: Experience managing capital project ($10-20MM budget) Excellent written and oral communication skills Bachelor's Degree in Engineering, Scientific, or Mathematical related field 5+ years of Project Management experience Nice to Have...
-
Capital Project Manager
2 weeks ago
Fort Washington, United States Insight Global Full timeJob Title: Project ManagerDuration: 1.5-2 year long contractLocation: Fort Washington, PARequired Skills and Experience:Experience managing capital project ($10-20MM budget)Excellent written and oral communication skillsBachelor's Degree in Engineering, Scientific, or Mathematical related field5+ years of Project Management experienceNice to Have Skills and...
-
Capital Project Manager
5 days ago
Fort Washington, United States Insight Global Full timeJob Title: Project ManagerDuration: 1.5-2 year long contractLocation: Fort Washington, PARequired Skills and Experience:Experience managing capital project ($10-20MM budget)Excellent written and oral communication skillsBachelor's Degree in Engineering, Scientific, or Mathematical related field5+ years of Project Management experienceNice to Have Skills and...
-
Capital Project Manager
6 days ago
Fort Washington, United States Insight Global Full timeJob Title: Project ManagerDuration: 1.5-2 year long contractLocation: Fort Washington, PARequired Skills and Experience:Experience managing capital project ($10-20MM budget)Excellent written and oral communication skillsBachelor's Degree in Engineering, Scientific, or Mathematical related field5+ years of Project Management experienceNice to Have Skills and...
-
Capital Project Manager
3 days ago
Fort Washington, United States Insight Global Full timeJob Title: Project ManagerDuration: 1.5-2 year long contractLocation: Fort Washington, PARequired Skills and Experience:Experience managing capital project ($10-20MM budget)Excellent written and oral communication skillsBachelor's Degree in Engineering, Scientific, or Mathematical related field5+ years of Project Management experienceNice to Have Skills and...
-
Capital Project Manager
1 day ago
Fort Washington, United States Insight Global Full timeJob Title: Project ManagerDuration: 1.5-2 year long contractLocation: Fort Washington, PARequired Skills and Experience:Experience managing capital project ($10-20MM budget)Excellent written and oral communication skillsBachelor's Degree in Engineering, Scientific, or Mathematical related field5+ years of Project Management experienceNice to Have Skills and...
-
Security Engineer
2 weeks ago
Washington, United States Global InfoTek Full timeClearance Level: Top Secret clearance with SCI eligibility US Citizenship: Required Job Classification: Full-time Location: District of Columbia Experience: 5 years of experience in system security analysis and implementation; secure system engineering or design; and work in protocol and/or interface standard. 10 years of experience in software engineering,...
-
Security Engineer ISSE
1 week ago
Washington, United States Global InfoTek Full timeClearance Level: Top Secret clearance with SCI eligibility US Citizenship: Required Job Classification: Full-time Location: District of Columbia Experience: 5 years of experience in system security analysis and implementation; secure system engineering or design; and work in protocol and/or interface standard. 10 years of experience in software engineering,...
-
Security Engineer
2 days ago
Washington, United States Global InfoTek Full timeClearance Level: Top Secret clearance with SCI eligibility US Citizenship: Required Job Classification: Full-time Location: District of Columbia Experience: 5 years of experience in system security analysis and implementation; secure system engineering or design; and work in protocol and/or interface standard. 10 years of experience in software engineering,...
-
Fort Washington, United States ClinChoice Full timeAssociate Director, Global Medical Safety Operations Physician. About ClinChoice ClinChoice is a clinical CRO dedicated to offering high-quality full development service to biopharmaceutical, medical device, and consumer products clients. Our services include clinical operations, project management, biostatistics, data management, regulatory affairs,...
-
Fort Washington, United States ClinChoice Full timeAssociate Director, Global Medical Safety Operations Physician. About ClinChoice ClinChoice is a clinical CRO dedicated to offering high-quality full development service to biopharmaceutical, medical device, and consumer products clients. Our services include clinical operations, project management, biostatistics, data management, regulatory affairs,...
-
Fort Washington, United States ClinChoice Inc Full timeJob DescriptionJob DescriptionAssociate Director, Global Medical Safety Operations Physician. About ClinChoiceClinChoice is a clinical CRO dedicated to offering high-quality full development service to biopharmaceutical, medical device, and consumer products clients. Our services include clinical operations, project management, biostatistics, data...
-
Fort Washington, United States ClinChoice Inc Full timeJob DescriptionJob DescriptionAssociate Director, Global Medical Safety Operations Physician. About ClinChoiceClinChoice is a clinical CRO dedicated to offering high-quality full development service to biopharmaceutical, medical device, and consumer products clients. Our services include clinical operations, project management, biostatistics, data...
-
Fort Washington, United States ClinChoice Inc Full timeJob DescriptionJob DescriptionAssociate Director, Global Medical Safety Operations Physician. About ClinChoiceClinChoice is a clinical CRO dedicated to offering high-quality full development service to biopharmaceutical, medical device, and consumer products clients. Our services include clinical operations, project management, biostatistics, data...
