Filtration Group: Manufacturer of mission-critical filtration and separation solutions.
5+ YOEBachelor's degree and 5+ years in quality systems; ISO 9001 management, audit leadership, CAPA, document control, training, and continuous improvement experience required.
Microsoft Office, quality management software systems
ebm-papst: Manufacturer of high-efficiency fans and motor technology systems.
5+ YOELead and manage quality programs, ISO 9001 maintenance, SPC data analysis, quality-engineering reviews, team leadership and reporting; bachelor’s or 5+ years related experience.
MAC-PAC, Order Processing, Inventory Systems, Design, Internet, Project Management, Microsoft Word, Microsoft Access, Microsoft Excel, Microsoft Visio
United States or Center Valley or Westborough or Brooklyn Park
$106k-$149k/yrRemoteFull Time
OlympusTokyo Stock Exchange: 7733: Manufactures medical endoscopes and minimally invasive surgical tools.
7+ YOEBachelor's degree and 7+ years in quality systems/document control/training in regulated environments; knowledge of FDA QSR and ISO 13485; DMS/LMS/EMQMS experience and strong project and communication skills.
Document Management Systems (DMS), Electronic Quality Management Systems, Learning Management Systems (LMS), Microsoft Office, ERP systems
MLC: Global supplier of high-calcium lime and calcium-based products.
5+ YOE2+ MgmtBachelor's in Chemistry, 5+ years in quality/food safety or regulatory compliance, 2+ years leading audits/CAPA, document control and audit management experience, strong communication and cross-functional collaboration skills.
McCarthy Holdings: National construction specializing in commercial and industrial projects.
2+ YOEManage document management system and policy governance; administer SharePoint; lead technical writers and people; enforce content governance, metadata, and lifecycle; drive process improvements and use Lucidchart/Mural; travel 30-50%.
SharePoint, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Lucidchart, Mural
Rochester Electronics: Licensed semiconductor manufacturer and distributor for end-of-life components.
10+ YOE5+ MgmtBachelor's degree in engineering or related field, 10 years quality management experience, 5+ years supervisory experience, semiconductor manufacturing experience, knowledge of ISO9000/IATF16949/AS9100/JEDEC, SPC/LEAN/6 Sigma, auditing and strong computer and communication skills.
C&A Tool: High-precision contract manufacturing for aerospace and medical sectors.
2+ YOEAdminister QMS (ISO/IATF), lead audits, analyze KPIs, train employees, resolve quality issues; 2–4 years QMS experience preferred and high school degree required.
ISO 9001, IATF 16949, ISO 13485, Microsoft Word, Microsoft Excel
TeleflexNYSE: TFX: Manufactures medical devices for critical care and surgical procedures.
8+ YOELead QMS, audits, CAPA and continuous improvement in a regulated manufacturing environment; bachelor's degree preferred or 8+ years quality experience; knowledge of FDA QSR, cGMP, ISO, SAP, eQMS, and statistical methods.
eQMS, ERP, SAP, Agile, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Minitab
Johnson ControlsNYSE: JCI: Produces and services HVAC, security, and building automation equipment.
5+ YOE5+ years quality auditing; experience in heavy industrial, automotive, aerospace, metal machining or welding; strong QMS knowledge; ISO 9000/TS 16949/AS 9100; proficient in MS Office, Minitab; lead improvement teams.
Tonix PharmaceuticalsNASDAQ: TNXP: Developing and commercializing therapeutics for CNS and immunological diseases.
8+ YOE8+ years in biotech/pharma, 4+ years in Quality Management Systems; Veeva Vault admin experience; strong documentation and cross-functional collaboration; travel up to 10%.
Veeva Vault, QDocs, eQMS, RIM, DocuSign, Microsoft Office
KagomeTokyo Stock Exchange: 2811: Manufacturer of tomato-based foods, sauces, and culinary ingredients.
7+ YOEBachelor's in a relevant scientific discipline, 7+ years food safety/quality experience in food manufacturing, knowledge of HACCP/SQF/GFSI/GMPs, audit management experience, Microsoft Office 365 proficiency, ability to travel and manage a team.
Microsoft Office 365, HACCP, GMPs, SQF, GFSI, Food Safety and Quality Management System, quality/document management systems
Quality Systems Manager – Medical Device Manufacturing
Fairfield, New Jersey, United States
OnsiteFull Time
Weiss-Aug Group: Provides precision metal stamping and injection molding manufacturing solutions.
10+ YOE10+ years in medical device quality systems; ISO 13485 and FDA QSR experience; manage QMS, audits, and regulatory readiness; Bachelor’s in Engineering or Quality.
Electronic QMS platforms, ISO 13485, FDA QSR, 21 CFR Part 820
Cretex Companies: Contract manufacturer of precision medical device components and infrastructure products.
5+ YOEBachelor's degree or 6 years equivalent experience; 5+ years managing QMS; ISO 13485 and FDA knowledge; Lead Auditor Certification; Microsoft Office and project management skills; team leadership and audit experience.
Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Publisher, E-Verify
STERISNYSE: STE: Provides infection prevention and procedural healthcare products and services.
10+ YOE6+ MgmtLead quality improvement across multi-site manufacturing; ensure ISO 9001, ISO 13485, MDSAP, CFR Part 820/211, EU MDR compliance; manage quality systems, supplier and process quality, and PRRC duties.
Excel, Word, PowerPoint, Visio, Statistical Analysis Software
Catalent: Global provider of drug development and manufacturing solutions.
4+ YOE4+ MgmtDegree in STEM with 4–9+ years related experience (depending on degree); experience with quality systems, investigations, CAPA, change control, auditing, training, and TrackWise; leadership experience expected.
GSKLondon Stock Exchange: GSK: Develops and manufactures innovative vaccines and specialty medicines.
6+ YOEBachelor’s degree in a scientific/technical/engineering field; 6+ years in pharma/biotech quality operations; experience with change control, deviations, CAPA, document control; experience with validation/qualification of equipment or computer systems.