23 quality systems specialist jobs at 17 companies in Intercourse, PA
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Quality Management Systems Specialist
Conshohocken or Ohio
OnsiteFull Time
Supports ISO 9001 quality systems, audits, document control, corrective actions, risk assessments, metrics, management of change, and quality training across facilities.
ISO 9001, CAPA
1mo
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Quality Systems Specialist II
Avondale, Pennsylvania, United States
OnsiteFull Time
3+ YOELead complaint investigations, return material evaluations, root cause analysis, CAPA development, risk assessments, and cross-functional improvement initiatives.
1mo
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Quality Systems Specialist
Breinigsville, Pennsylvania, United States
$94k-$123k/yr OnsiteFull Time
Bachelor's in food science/microbiology/chemistry, experience with analytical testing and food microbiology, knowledge of shelf-life and ingredient functionality, data analysis and DOE experience, strong communication and technical writing.
Microsoft Excel, Minitab, Design of Experiments (DOE)
1w
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Quality Specialist
Aston, Pennsylvania, United States
OnsiteFull Time
1+ YOEHigh school diploma or equivalent required. Requires 1 year of leadership or regulated-environment experience, quality systems knowledge, strong customer service, critical reasoning, organization, and problem-solving skills.
Learning Management System, Quality Management System, TrackWise, Standard Operating Procedures (SOPs), cGMP, FDA, OSHA, CLIA, COLA, HIPAA
1w
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Quality Specialist
Aston, Pennsylvania, United States
OnsiteFull Time
1+ YOEHigh school diploma required; associate or bachelor's degree preferred. Requires one year of leadership or regulated-environment experience, quality systems knowledge, strong reasoning, decision-making, problem-solving, customer service, and organizational skills.
Learning Management System, Quality Management System, TrackWise, CLIA, COLA, cGMP, FDA, OSHA, HIPAA
3w
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Quality Technical Specialist
Leesport, Pennsylvania, United States
OnsiteFull Time
5+ YOEHigh school diploma or equivalent and 5 years of quality experience in manufacturing. Requires knowledge of manufacturing systems, quality functions, technical products, and preferably ISO 9001 system elements.
ISO 9001
3d
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Operational Quality Specialist
Marietta, Pennsylvania, United States
OnsiteFull Time
2+ YOEBachelor's degree or equivalent technical experience; 2+ years in a regulated industry; 1+ year with GMP, FDA, and regulatory compliance; experience in QA, validation, aseptic processing, quality systems, batch records, and DMAIC.
DMAIC, FDA, NIH Guidelines, GMP, ALCOA+, CAPA, PQR
1mo
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Quality Assurance Specialist
Gibbstown, New Jersey, United States
$80k-$100k/yr OnsiteFull Time
5+ YOE5+ years QA/ISO quality system experience, cGMP and ISO 13485 knowledge, auditing and complaint/CAPA experience, strong analysis and writing skills, Microsoft Office proficiency, bachelor’s in technical field preferred.
Microsoft Outlook, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, MasterControl
1mo
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Quality Specialist
Kulpsville, Pennsylvania, United States
OnsiteFull Time
2+ YOE2+ years relevant experience, HS diploma required (degree preferred). Experience with quality auditing, ISO/AS systems, GD&T, LSS, and cross-functional communication.
E-IPC, Infinity QS, SAP, FAIR
1mo
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Quality Assurance Specialist
Gibbstown, New Jersey, United States
$80k-$100k/yr OnsiteFull Time
5+ YOE5+ years QA experience with ISO systems and FDA cGMP knowledge; strong auditing, problem-solving, writing, and project management skills; Microsoft Office proficiency; Bachelor's in technical field preferred.
Microsoft Outlook, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, MasterControl
3mo
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Quality Specialist 2nd Shift
Lyon Station, Pennsylvania, United States
OnsiteFull Time
2+ YOEPerform quality inspections, audits, data analysis, and corrective actions in a battery manufacturing environment; familiarity with QA systems, PFMEA, Lean/5S/Six Sigma concepts; effective communication and attention to detail.
PFMEA, Microsoft Office
2mo
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Specialist Nursing Quality - Adult Emergency Department
Hershey, Pennsylvania, United States
OnsiteFull Time
3+ YOEBachelor's in Nursing, 3 years nursing experience, active RN license in state or multistate compact, BLS; experience with nursing quality systems, compliance documentation, and quality initiatives.
1w
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QA Specialist-GLP/BIO
Exton, Pennsylvania, United States
OnsiteFull Time
Bachelor's degree in a relevant scientific discipline or equivalent experience; quality assurance and quality systems experience; bio-analytical laboratory experience preferred; knowledge of FDA, OECD, ICH, and GLP requirements.
Standard Operating Procedures (SOPs), 21 CFR Part 58, 21 CFR Part 11, 21 CFR Part 320, 40 CFR Part 160, CAPA, GLP
1w
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Lead Post Market Surveillance Specialist
Newark, Delaware, United States
$116k-$182k/yr OnsiteFull Time
8+ YOEBachelor's degree in a technical discipline and 8+ years in medical devices, healthcare, life sciences, or regulated industries. Requires complaint trending, surveillance analytics, statistical methods, quality systems, and signal detection expertise.
Power BI, SQL, Minitab, Tableau, ANSI/ASQ Z1.4
1w
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Tester/Testing Specialist
Harrisburg, Pennsylvania, United States
$71k-$139k/yr OnsiteFull Time
5+ YOERequires 5 years of relevant software testing experience, automated test case development, and US citizenship with Secret clearance. Experience in system, regression, acceptance, end-to-end, performance, and automation testing.
automated test tools
1mo
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Lead Specialist, Sterilization and Microbiology - Exton, PA
Exton, Pennsylvania, United States
$66k-$90k/yr OnsiteFull Time
3+ YOEBachelor's in biological science, 3+ years QA/QC experience in microbiological control within medical device/pharmaceutical manufacturing; sterilization methods knowledge, ISO13485 and FDA regulations, strong quality systems and statistical skills.
Microsoft Office, SAP, Document Management Systems
1mo
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Lead Specialist, Sterilization and Microbiology - Exton, PA
Exton, Pennsylvania, United States
$66k-$90k/yr OnsiteFull Time
3+ YOEBachelor's in biological science required, 3+ years QA/QC microbiology experience in medical device/pharmaceutical manufacturing, sterilization experience (gamma,Ebeam,EtO), EM/environmental monitoring, knowledge of ISO13485, FDA 21CFR820, and quality systems.
Microsoft Office, SAP, Document Management Systems
3mo
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Lean Manufacturing Specialist
Owings Mills, Maryland, United States
$85k-$110k/yr OnsiteFull Time
4+ YOEBachelor's degree; 4+ years applying Lean manufacturing; strong data analysis; ERP experience; ISO/quality system experience; MS Office skills; problem-solving in cross-functional teams.
MS Excel, PowerPoint, Teams, Word, ERP systems
1mo
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Inventory Control Specialist - 3PL
Telford, Pennsylvania, United States
OnsiteFull Time
1+ YOELead inventory control and quality initiatives, perform cycle counts, reconcile discrepancies, develop SOPs, operate PIT equipment, lift up to 100 lbs, and use MS Office and warehouse systems.
Microsoft Outlook, Microsoft Word, Microsoft PowerPoint, Microsoft Excel, SAP, EWM
2mo
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Adverse Event Reporting Spec II, Temporary (6 months)
Elkton, Maryland, United States
OnsiteFull Time, Temporary
3+ YOESupport post-market surveillance and medical device reporting (MDR) to US and global health authorities; review complaints for reportability, coordinate information requests, maintain MDR logs, assist audits and implement quality system improvements. Requires regulatory knowledge and MS Office proficiency.
Microsoft Office, Document Control software applications
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