Boston ScientificNYSE: BSX: Developer and manufacturer of innovative medical devices and therapies.
5+ YOEBachelor's degree plus 5 years or master's degree plus 3 years; experience leading complex quality system projects, CAPA, audits, regulatory inspections, and medical device compliance.
Corrective and Preventive Action (CAPA), 21 CFR Part 820, Quality Management System Regulation (QMSR), ISO 13485, EU MDR, MDSAP, ISO 14971
Boston ScientificNYSE: BSX: Developing and manufacturing innovative medical devices for less-invasive treatments.
3+ YOEBachelor's degree in a technical discipline with 5+ years' experience or master's degree with 3+ years; quality systems, CAPA, audits, medical device regulations, project management, and cross-functional leadership experience.
21 CFR Part 820, Quality Management System Regulation (QMSR), ISO 13485, EU MDR, MDSAP, ISO 14971
Boston ScientificNYSE: BSX: Manufacturer of interventional medical devices and technologies.
5+ YOEBachelor's degree plus 5 years or master's degree plus 3 years of experience; requires quality systems, medical device regulations, CAPA, audits, project management, and cross-functional leadership expertise.
Corrective and Preventive Action (CAPA), 21 CFR Part 820, Quality Management System Regulation (QMSR), ISO 13485, EU MDR, MDSAP, ISO 14971
Trystar: Designs and manufactures electrical power distribution and backup equipment.
3+ YOE3+ years in quality systems/assurance/engineering in manufacturing, working knowledge of ISO 9001, QMS administration (ETQ preferred), audit and CAPA support, Microsoft 365 proficiency, strong communication and attention to detail.
Parker HannifinNYSE: PH: Manufacturer of motion and control technologies and systems.
Bachelor's in engineering, experience with ISO 9001:2015 and quality engineering methods, familiarity with APQP/PPAP/MSA/SPC, Lean/Six Sigma, ERP/MRP and quality systems; ASQ/CQE/CQA or Six Sigma certification preferred.
ISO 9001:2015, APQP, PPAP, MSA, SPC, ERP/MRP, Lean Manufacturing, Six Sigma
Koch Inc.: Operates global manufacturing, refining, and industrial technology businesses.
2+ YOELead product quality and validation for NPI and volume production; 2+ years manufacturing experience or Bachelor's/4+ years quality experience; knowledge of SPC/DOE, CAPA, audits, and quality systems.
SAP, SPC, Design of Experiment (DOE), AQP, FDA, ISO
TrelleborgNasdaq Stockholm: TREL B: Develops engineered polymer solutions to seal, damp, and protect.
2+ YOERequires a 4-year degree in quality, engineering, or a related field and 2+ years in a manufacturing technical support role; knowledge of medical device quality systems and validation is required.
ISO 13485, ISO 9000, ISO 9001, FDA 21 CFR 820, FDA 21 CFR 11, EU/MDR, ITAR, Process Failure Modes and Effects Analysis (pFMEA), Gage Repeatability and Reproducibility (GRR), Measurement System Analysis (MSA), DOE, ANOVA, CAPAs, IQ/OQ/PQ
DoverNYSE: DOV: Manufactures diversified industrial equipment and engineered components globally.
10+ YOEBachelor's in Engineering, 10+ years in quality or manufacturing, proficiency with ISO 13485/9001 and quality systems, strong problem-solving and communication skills, ability to perform root cause analysis and CAPA.
Heraeus: Global technology specializing in materials and medical components.
5+ YOEBachelor's degree in engineering preferred, 5+ years relevant experience required, and expertise in quality systems, statistical analysis, validation, nonconformance, audits, and medical device manufacturing.
Cretex Companies: Contract manufacturer of precision medical device components and infrastructure products.
3+ YOEBachelor's in engineering, 3+ years manufacturing engineering experience, knowledge of quality systems and regulatory requirements, blueprint reading and GD&T, inspection equipment operation, DOE and capability studies, ERP and Microsoft Office proficiency.
Minitab, ERP, Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Publisher
Seaway Plastics Engineering: Produces custom plastic injection molded parts and complex assemblies.
4+ YOEB.S. in Engineering or equivalent experience, 4+ years in regulated manufacturing, IQ/OQ/PQ validation, ISO 13485 and FDA quality system knowledge, audit support, root cause analysis, GD&T, Epicor experience preferred.
Epicor, ISO 13485, GD&T, Lean, Six Sigma, 8D, DMAIC, A3, IQ, OQ, PQ, CAPA, SCAR, RMA, NCR, MRB
MME Group: Provider of custom plastic injection molding and contract manufacturing services.
4+ YOEB.S. in Engineering or equivalent, 4+ years in regulated manufacturing, experience with IQ/OQ/PQ validation, ISO 13485 and FDA quality systems, root cause analysis, print reading, cGMP/cGDP, GD&T, ERP (Epicor) experience preferred.
Epicor, ERP, Lean, Six Sigma, DMAIC, 8D, A3, IQ, OQ, PQ, ISO 13485, cGMP, cGDP, GD&T, CAPA
DanaherNYSE: DHR: Develops scientific instruments and diagnostic tools for healthcare markets.
7+ YOEBachelor's or Master's in a technical field with extensive quality/supplier quality experience, 7+ years in quality engineering, knowledge of quality systems, risk management, CAPA, statistical methods, strong communication, and up to 15% travel.
Lexington Manufacturing: Manufacturer of engineered wood components for windows and doors.
3+ YOEBachelor's degree or CQE, 3+ years quality experience in manufacturing, knowledge of ISO, SPC, auditing, APQP/PPAP, 8D/DMAIC, strong communication, and proficiency with Microsoft Office and ERP/SPC systems.
rms Company: Manufactures precision medical implants and components for medical OEMs.
Bachelor's in engineering, knowledge of quality systems, GD&T, inspection equipment, data analysis, and Microsoft Office; ability to support audits and validation activities.
Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Publisher
BaxterNew York Stock Exchange: BAX: Develops and manufactures medical devices, pharmaceuticals, and IV solutions.
5+ YOEBachelor's in science/engineering, 5+ years quality experience in medical device, audit experience, strong knowledge of FDA/ISO regulations (ISO 13485, 21 CFR 820), QMS expertise, communication, project management, and continuous improvement skills.
RTXNYSE: RTX: RTX provides advanced aerospace and defense systems and services.
5+ YOEDegree in STEM with 5+ years relevant experience (or advanced degree with 3+ years). Experience in manufacturing, APQP, PPAP, RCCA, 8D, continuous improvement, and quality system standards.
APQP, AS9145, AS13100, 8D, RCCA, PPAP, MPR, ETQP, Stride, PFMEA, Control Plan, Gage Capability, Process Capability, AS/EN9100, ISO-9001