Loos & Co: Manufactures mission-critical wire, rope, and cable assemblies.
10+ YOE10+ years quality experience in AS9100 manufacturing, supervisory experience, inspection and measurement skills, root cause analysis, CAPA, strong communication, and Microsoft Office proficiency.
CooperSurgicalNasdaq: COO: Manufactures medical devices for fertility and women's health.
7+ YOERequires 7+ years in regulated quality environments, 5+ years in supplier quality management, and a bachelor's degree or equivalent experience. Expertise in supplier audits, risk management, SCAR/CAPA, regulatory standards, and quality systems.
FDA QSR (21 CFR 820), ISO 13485, EU MDR, ISO 14971, Minitab, Microsoft Office, ERP, eQMS, SCAR, CAPA, FMEA, NCMRs, SCNs, NPI, IQ, OQ, PQ, PPAP, QMS
Greenfield Global: Produces high-purity alcohols, specialty solvents, and sustainable biofuels.
7+ YOEBachelor's degree, 7+ years in quality or supplier quality within a GMP/ISO regulated environment; working knowledge of ISO 9001, IPEC-PQG GMP, EXCiPACT; experience with supplier audits, supplier development, QMS, SCAR/CAPA, and risk-based supplier quality.
ISO 9001, IPEC-PQG GMP, EXCiPACT, QMS, SCAR, CAPA, Management of Change (MoC)
Sheffield Pharmaceuticals: Manufacturer of over-the-counter pharmaceuticals and personal care products.
Maintain QA documentation, review batch records, coordinate CAPAs and audits. Requires attention to detail, knowledge of cGMP and good documentation practices, and proficiency with Word, Excel, and PowerPoint.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint
HyperfineNasdaq: HYPR: Develops and sells portable MRI brain imaging systems.
5+ YOELead supplier quality activities including supplier qualification, audits, NCs/CAPAs/SCARs, product release, risk management, and continuous improvement in a regulated medical device environment.
BDNYSE: BDX: Manufactures medical devices, surgical instruments, and pharmacy automation systems.
3+ YOEBachelor's degree, 3 years manufacturing experience, strong problem-solving and CI skills, experience with process validation, CAPA, change control, and manufacturing quality support for 24/7 operations.
Tirlán: Farmer-owned cooperative producing dairy, grain, and animal nutrition.
5+ YOEBachelor's degree in engineering or a related technical field, 5+ years in manufacturing, quality, process engineering, or continuous improvement, and CAPA, root cause analysis, statistical analysis, and project leadership experience.
5 Why, Fishbone, Fault Tree Analysis, Lean Manufacturing, Six Sigma, Kaizen, Statistical Process Control (SPC), Minitab, Microsoft Power BI, HACCP, FDA, GMP
Curtiss-WrightNYSE: CW: Engineers and manufactures critical components for aerospace and defense.
1+ YOEInspect materials and products, perform measurements and tests, document results, identify non-conformances, support CAPA, read blueprints, and use measuring instruments; 1-2 years inspection experience preferred.
MedtronicNew York Stock Exchange: MDT: Develops and manufactures medical devices and digital health solutions.
4+ YOEDegree in packaging/mechanical/manufacturing engineering, 4+ years experience (Bachelors) or equivalent, experience in regulated packaging operations, IQ/OQ/PQ validation, CAPA, Lean/Six Sigma, and project management skills.
First Class Air Support: Distributes aftermarket aircraft components and provides aviation repair services.
7+ YOE3+ Mgmt7–10+ years in an FAA Part 145 repair station or aviation MRO, 3+ years leadership in quality/safety/inspection, knowledge of FAA/EASA regulations, ability to manage SMS, CAPA, audits, inspections, and airworthiness release processes.
FAA Form 8130-3, EASA Form 1, Safety Management System (SMS)
Director, Quality Systems & Regulatory Affairs (Remote - East Coast)
Darien, Connecticut, United States
$160k-$180k/yrRemoteFull Time
CEFALY Technology: Manufacturer of wearable medical devices for migraine relief.
8+ YOERequire 8+ years QA/RA medical device experience, bachelor’s degree, eQMS ownership experience (Greenlight Guru preferred), lead audits/inspections, FDA/EU regulatory submissions, and experience with CAPA, risk management, and document control.
Development Scientist II, Analytical Development and Clinical QC (ADQC)
New Haven, Connecticut, United States
OnsiteFull Time
Alexion Pharmaceuticals: Develops and manufactures treatments for rare and ultra-rare diseases.
2+ YOEResponsible for owning laboratory investigations (LIRs), closing OOS/OOT investigations, performing root cause analysis and CAPA, reviewing analytical data, ensuring cGMP compliance, and collaborating with QA/AD/stability; advanced degree in biochemistry/chemistry (MS or PhD) with relevant analytical development experience required.
Veeva Vault (EQV), LIMS, ValGenesis, Kneat, JMP, Tableau, SAS, Microsoft SharePoint, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
Celldex TherapeuticsNASDAQ: CLDX: Developing antibody-based immunotherapies for inflammatory and autoimmune diseases.
3+ YOEBachelor's degree or equivalent experience; 5–8 years in biotechnology or pharmaceuticals, including 3+ years in clinical or medical operations. Requires vendor oversight, global program, regulatory, metrics, and project management experience.
GxP, Standard Operating Procedures (SOPs), 21 CFR Part 312, Key Performance Indicators (KPIs), Service Level Agreements (SLAs), Corrective and Preventive Action (CAPA)
ALK-AbellóNasdaq Copenhagen: ALKB: Developing and manufacturing allergy immunotherapy and diagnostic products.
5+ YOE5+ MgmtPreferred bachelor's degree in life sciences, biology, chemistry, or related field; 5+ years of progressive laboratory management experience in pharmaceutical or GMP settings; knowledge of cGMP, USP, FDA, and ICH guidelines.
The Jackson Laboratory: Conducts genomic research and produces specialized laboratory mouse models.
7+ YOE2+ MgmtBachelor's degree, 7 years of quality experience, 2 years of supervisory experience, risk management and quality systems expertise, ISO 9001 knowledge, and pharmaceutical or biotechnology leadership experience.
Design FMEA, Process FMEA, pFMEA, Root Cause Analysis (RCA), MSA/Gauge R&R, ISO 9001, Computer System Validation, Quality by Design (QbD), Lean, Six Sigma, CAPA
908 DevicesNASDAQ: MASS: Handheld mass spectrometry devices for on-site chemical analysis.
5+ YOEBachelor's in engineering (Masters preferred), 5+ years quality engineering in electromechanical manufacturing, experience leading root cause analysis and corrective actions, familiarity with ISO 9001 and IPC-A-610, structured problem-solving (8D, FMEA, SPC), <10% travel.