Senior Quality Engineer

Join to apply for the Senior Quality Engineer role at Katalyst CRO Continue with Google Continue with Google 2 weeks ago Be among the first 25 applicants Join to apply for the Senior Quality Engineer role at Katalyst CRO Get AI-powered advice on this job and more exclusive features. Sign in to access AI-powered advices Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Continue with Google Evaluate and improve contract manufacturers' processes through research, design, and collaboration. Develop and optimize manufacturing processes and equipment in partnership with vendors. Onboard and manage contract manufacturers, ensuring regulatory compliance. Enhance manufacturing efficiency through workflow and layout analysis. Design and implement testing methods to ensure product and process quality. Serve as a key resource for manufacturing and quality-related inquiries. Ensure compliance with regulatory standards to maintain product reputation. Support design and development projects, including training contract manufacturers. Maintain quality engineering functions such as supplier controls, audits, and validations. Participate in Material Review Board and CAPA processes to address non-conformances. Drive continuous improvement of the Quality Management System (QMS). Conduct internal and supplier quality audits. Create and maintain documentation for product specifications, validations, and design history files. Support QMS functions such as document control, training, and device history record management. Responsibilities Evaluate and improve contract manufacturers' processes through research, design, and collaboration. Develop and optimize manufacturing processes and equipment in partnership with vendors. Onboard and manage contract manufacturers, ensuring regulatory compliance. Enhance manufacturing efficiency through workflow and layout analysis. Design and implement testing methods to ensure product and process quality. Serve as a key resource for manufacturing and quality-related inquiries. Ensure compliance with regulatory standards to maintain product reputation. Support design and development projects, including training contract manufacturers. Maintain quality engineering functions such as supplier controls, audits, and validations. Participate in Material Review Board and CAPA processes to address non-conformances. Provide design control support for new product development, including risk management. Drive continuous improvement of the Quality Management System (QMS). Conduct internal and supplier quality audits. Create and maintain documentation for product specifications, validations, and design history files. Support QMS functions such as document control, training, and device history record management. Requirements : Bachelor's degree in engineering or a related technical field, or equivalent experience. 6-8 years of experience in manufacturing and supplier quality engineering. Experience with process validations and contract manufacturer management. Background in medical devices and FDA-regulated industries. Strong knowledge of ISO 13485 standards. Excellent communication, organizational, and project management skills. Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint). Strong analytical and problem-solving abilities with a proactive mindset. Seniority level Seniority level Mid-Senior level Employment type Employment type Contract Job function Job function Quality Assurance Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Senior Quality Engineer” roles. Continue with Google Continue with Google Continue with Google Continue with Google Marlborough, MA $120,000 - $199,000 1 week ago Senior Hardware Quality Engineer (Accessories) Sr. Quality Engineer [Must Have Design Control] Senior Quality Engineer, Post Market (Hybrid - Acton, MA.) Acton, MA $85,125.00 - $127,687.50 2 weeks ago Quality Engineering Manager, Post-Market Risk - Sr. Quality Engineer (Must Have Exp @ MFG Facility with MFG Operations) Marlborough, MA $94,000.00 - $118,000.00 1 week ago Tewksbury, MA $82,000.00 - $164,000.00 11 hours ago Sr Verification & Validation Design Engineer, Consumables and Capital Newton, MA $133,900.00 - $200,900.00 2 months ago Burlington, MA $100,000.00 - $160,000.00 2 weeks ago Senior Quality Engineer (including machined parts) Acton, MA $89,000.00 - $101,000.00 3 days ago Westford, MA $75,300.00 - $150,700.00 3 days ago Northborough, MA $115,000.00 - $135,000.00 2 days ago Marlborough, MA $97,800 - $155,000 1 week ago North Billerica, MA $120,000 - $135,000 3 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr