FluenceNasdaq: FLNC: Provides energy storage systems and optimization software for renewables.
15+ YOE15+ years quality leadership in manufacturing/energy; bachelor's in engineering or related; expertise in QMS, ISO, CAPA, reliability engineering; Lean/Six Sigma experience; executive leadership and global operations experience.
Quality Management System (QMS), ISO, CAPA, Lean, Six Sigma
AbbottNYSE: ABT: Manufactures medical devices, diagnostics, and nutritional health products.
2+ YOEBachelor's in engineering or technical field, 2+ years engineering experience, knowledge of FDA/GMP/ISO standards, experience with quality tools (DMAIC, CAPA, NCR), statistical/data analysis skills, medical device experience preferred.
DMAIC, Lean Manufacturing, Six Sigma, IQ/OQ/PQ, TMV, ISO 13485, ISO 14971, FDA 21 CFR Part 820, CAPA, NCR, Root Cause Analysis
CooperSurgicalNasdaq: COO: Manufactures medical devices for fertility and women's health.
0+ YOEPerform visual, dimensional, mechanical and functional inspections; document results; identify and report nonconformances; follow procedures and support CAPA and audits.
Microsoft Excel, Microsoft Word, Microsoft Teams, Outlook, PowerPoint, calipers, micrometers, gauges, vision systems
PCCA: Supplies chemicals, equipment, and training to compounding pharmacies.
5+ YOEBachelors in science required. Experience with GMP, investigations, CAPA, audits, quality metrics, and MasterControl; 5+ years conducting investigations in FDA-regulated environments preferred.
ImmaticsNASDAQ: IMTX: Develops T-cell receptor-based immunotherapies for cancer treatment.
4+ YOEAssociate's or Bachelor's in a scientific field, 4+ years GMP manufacturing experience, aseptic/cleanroom experience, ALCOA++/cGDocP documentation, deviation/CAPA investigations, and mentoring experience.
ProEnergy: Manufacturer and service provider for aeroderivative power generation equipment.
3+ YOEBachelor’s degree in Engineering; 3+ years in Quality Engineering in manufacturing/MRO; ISO 9001; NCR/CAPA; data analysis; cross-functional collaboration; English fluency; US work authorization.
STERISNYSE: STE: Provides infection prevention and procedural healthcare products and services.
5+ YOEBachelor's in Engineering, 5+ years quality/manufacturing experience in ISO-certified and regulated (medical device) environments, familiarity with QMSR/GMP, leads audits and CAPA, ability to travel 10-20%.
Tramontina USA: Manufactures and distributes premium cookware and kitchen houseware products.
3+ YOE3+ years QA experience in manufacturing or consumer products; knowledge of ISO 9001, CAPA, document control, calibration, root cause analysis, retail compliance portals, laboratory testing, and corrective actions.
Monday.com, Walmart Retail Link, Costco systems, Tracegains, Mars repositories, ISO 9001, FMEA, SPC, Lean Six Sigma
AmphenolNYSE: APH: Manufactures electronic and fiber optic connectors and interconnect systems.
3+ YOEBachelor's degree in engineering or equivalent experience, 3+ years in quality engineering or customer-facing technical roles, expertise in root cause analysis and CAPA, strong communication, proficiency with quality/statistical tools.
Minitab, JMP, Microsoft Excel, Power Query, Power BI, Tableau, Salesforce/Service Cloud, ServiceNow, JIRA
HuntsmanNYSE: HUN: Manufactures and markets chemical products for consumer and industrial markets.
3+ YOESupport site QMS and ISO 9001:2015 compliance, perform laboratory testing and data analysis, lead root-cause investigations (5 Whys, 8D, CAPA), and manage SAP QM processes.
Blue Energy: Building modular nuclear power plants using shipyard manufacturing techniques.
12+ YOE3+ MgmtBachelor's in engineering,12+ years engineering experience with 5+ years in technical authority roles,knowledge of US codes/standards,nuclear QA,RCA/CAPA,MOC,and team leadership;PE or equivalent preferred.
ASME BPVC Section III, ASME NQA-1, ASME B31, IEEE, ANSI, 10 CFR 50 Appendix B, Bentley ProjectWise, Autodesk Construction Cloud, Microsoft SharePoint, Power BI, AVEVA E3D, SmartPlant, Revit, Navisworks
Systel: Designs and manufactures rugged computing systems for extreme environments.
2+ YOE2+ years QA experience in engineering, proficiency with CAPA/NCR/FAI, ability to interpret mechanical drawings, perform inspections, conduct root-cause analysis, and ensure compliance with ISO 9001/AS9100/ITAR.
Microsoft Word, Microsoft Excel, Microsoft Outlook, Microsoft Teams
Cellipont Bioservices: Contract development and manufacturing organization for cell therapies.
5+ YOE3+ MgmtBachelor's in life sciences or chemical engineering, minimum 5 years GMP manufacturing experience, 3 years leadership in GMP, aseptic technique expertise, SOP/MBR/CAPA experience, Word and Excel proficiency.
5+ YOEBachelor's in engineering or equivalent, 5+ years quality engineering in manufacturing (aerospace/automotive/energy storage preferred), AS9100/ISO9001 experience, RCA/CAPA leadership, data analysis (Python, Minitab), MS Office proficiency.
Python, Minitab, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook
LonzaSIX Swiss Exchange: LONN: Manufactures medicines and provides development services for healthcare companies.
5+ YOE5+ years QA experience in GMP-regulated environments, Bachelor's in a scientific discipline required, supervisory experience, strong cGMP and quality systems knowledge, investigations/CAPA/change control experience, cleanroom/gowning experience.
AmphenolNYSE: APH: Designs and manufactures electrical connectors and interconnect systems.
3+ YOEBachelor's in engineering or equivalent, 3+ years quality/customer-facing experience, expertise in root cause/CAPA (8D, 5 Whys, DMAIC), proficiency with quality/statistical tools and data analysis, strong communication skills.
Minitab, JMP, Microsoft Excel, Microsoft Power Query, Microsoft Power BI, Tableau, Salesforce Service Cloud, ServiceNow, JIRA, CMM
Integra Mission Critical: Design and delivery of modular, turnkey data center infrastructure.
10+ YOE3+ Mgmt10+ years QMS experience with 3+ years leading QMS or audit programs; strong ISO 9001, internal auditing, CAPA, document control, and corrective action skills; travel 10-20%; excellent communication.
Wellbore Integrity Solutions: Provides services and products for wellbore integrity.
10+ YOE10+ MgmtBachelor's in engineering or related field, 10+ years progressive quality/operations leadership, API/ISO certification program experience, supplier quality and auditing, CAPA/RCA, Lean/Six Sigma background; preferred relevant certifications.
Clinical Research, Sr Training and Compliance Coordinator
Phoenix or Pittsburgh or Friendswood or United States
RemoteFull Time
Castle BiosciencesNASDAQ: CSTL: Develops genomic tests to improve cancer treatment decisions.
3+ YOE3+ years clinical research and 3+ years training design experience in regulated environments; knowledge of GCP, FDA, ICH, ISO 14155, SOPs, CAPA; bachelor's in life sciences or related field preferred or equivalent experience.