AMETEKNYSE: AME: Manufacturer of electronic instruments and electromechanical devices.
5+ YOE5+ years quality leadership in manufacturing, ISO QMS development and maintenance, Six Sigma/Lean experience, quality/lean certification, strong analytical and communication skills.
Microsoft Excel, Microsoft Word, Microsoft PowerPoint
Resonetics: Engineering and manufacturing solutions for medical devices.
8+ YOERequires 8+ years of quality engineering experience in medical device manufacturing or equivalent, team leadership, audit experience, technical writing, statistical software, and a bachelor's degree or equivalent.
The Partner Companies: Global manufacturer of mission-critical precision components and specialty materials.
5+ YOE5+ Mgmt5+ years managing production employees with quality responsibilities; experience with QMS for ISO9001/AS9100; Bachelor's preferred; Lean/Six Sigma preferred; advanced Microsoft Excel/Word/PowerPoint skills.
Microsoft Excel, Microsoft Word, Microsoft PowerPoint
SafarilandNYSE: CDRE: Manufacturer of tactical holsters and body armor for professionals.
5+ YOELead ISO 9001 compliance and QMS, manage audits, lead quality team, drive CAPA and continuous improvement (Lean/Six Sigma), supplier quality, inspection/testing, and use measuring/calibration tools.
Microsoft Word, Microsoft Excel, Microsoft Access, Microsoft PowerPoint
Mayhew Steel Products: Manufactures professional-grade hand tools and automotive maintenance equipment.
5+ YOE3+ Mgmt5–7 years in quality in injection molding; 3+ years in leadership; ISO 9001:2015, MIL-SPEC, UL; QA tools proficiency; hands-on leader in a fast-paced environment.
PhilipsEuronext Amsterdam: PHIA: Manufactures medical imaging systems and personal care appliances.
8+ YOERequires 8+ years in FDA-regulated medical device environments, quality management and design assurance leadership, medical device regulatory knowledge, CAPA and audit experience, and a bachelor's degree in quality, engineering, or a related discipline.
FDA QMSR, ISO 13485, European Medical Device Regulation (MDR), ISO 14971, 21CFR, MDD, GMP, GDP, DFMEA, PFMEA, CAPA, Lean, Six Sigma, HSA
Mevion Medical Systems: Mevion Medical Systems provides compact proton therapy solutions for cancer treatment.
8+ YOE3+ MgmtBachelor's in engineering or equivalent, 8+ years quality experience in medical device manufacturing, 3+ years managing quality teams, strong ISO 13485 and risk-based quality knowledge, NCR/MRB/CAPA ownership, audit support, and continuous improvement expertise.
G.S. Precision: Manufactures precision components for aerospace and defense industries.
7+ YOE3+ MgmtBachelor's in engineering or related required; 7–10 years quality management experience with 3–5 years leadership; preferred ASQ/ISO/Nadcap credentials; experience with AS9100, Nadcap, ISO 9001, PPAP, APQP, FMEA, SPC, CAPA.
Microsoft Office, AS9100, Nadcap, ISO 9001, PPAP, APQP, FMEA, SPC, CAPA, 8D, Root Cause Analysis, Lean Manufacturing, Six Sigma
Borg Design: Borg Design provides precision CNC machining and contract manufacturing services.
5+ YOE5+ years QC/quality management in a machine shop, blueprint reading, use of calipers/micrometers/height gauges/thread gages, supervising inspection staff, FAI preparation, CAPA/root cause analysis; US citizen or permanent resident; fluent English.
calipers, micrometers, height gauge, thread gage, CNC, FAI
Sarepta TherapeuticsNASDAQ: SRPT: Develops precision genetic medicines for rare diseases.
8+ YOEBS/BA in a scientific discipline and 8+ years in a related industry, including 6+ years in Clinical Quality Assurance, clinical trial teams, audits, GCP, ICH, FDA, EU requirements, and Quality Management Systems.
GCP, FDA, ICH, CAPA, GxP, Quality Management System
S&R Corporation: General contractor specializing in heavy civil construction and demolition.
10+ YOE10+ years highway bridge construction; NETTCP QA Technologist; BS in engineering or 5+ years management/materials testing; design-build experience; read plans; MS 365 and Bluebeam; strong leadership and communication; able to work on active construction sites.
Lifepoint Health: Operates community hospitals and specialized healthcare delivery networks.
Bachelor's degree in a related field preferred, or equivalent applicable work experience; experience managing staff, budgets, compliance, patient-care quality, and evidence-based practices.
Granite State Manufacturing: Manufactures precision specialized equipment for defense and maritime industries.
5+ YOE3+ MgmtBachelor's degree (or equivalent) with 5+ years related experience, 3+ years people leadership, strong knowledge of AS9100/ISO 9001, GD&T (ASME Y14.5), ERP/MRP and Microsoft Office, and background sufficient for government security clearance.
Microsoft Office, Windows, ERP, MRP, AS9100, ISO 9001, APQP/AS9145, GD&T (ASME Y14.5), Lean, Six Sigma, Kaizen
ArdelyxNASDAQ: ARDX: Discovers and develops medicines for unmet medical needs.
10+ YOEBachelor’s degree in science or related field; 10+ years GxP QA in biotech; CMC QA experience; GMP knowledge; QA systems expertise; strong writing skills; advanced software skills.
RepligenNASDAQ: RGEN: Develops and manufactures bioprocessing technologies for pharmaceutical drug production.
12+ YOE5+ MgmtLead supplier quality oversight for Systems, Process Analytics, and filtration networks; manage SCARs, supplier qualification and development; travel to suppliers.
ISO 9001, ISO 13485, Lean manufacturing, Root Cause Analysis, FMEA, Statistical Process Controls
Senior Manager Quality, EM&S Gen Med North America
Framingham, Massachusetts, United States
$90k-$130k/yrHybridFull Time
SanofiEuronext Paris: SAN: Researches, develops, and manufactures medicines and vaccines globally.
3+ YOEBachelor's in a science field, 3+ years in pharmaceutical or quality operations with cGMP experience, strong cGMP/QMS knowledge, audit and CAPA experience, project management, and willingness to travel 25–30%.