Sr. Systems Quality Engineer

3 days ago Be among the first 25 applicants This range is provided by Insight Global. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $120,000.00/yr - $145,000.00/yr Job Description: Job Title: Sr. Systems Quality Engineer Location – On-site: Bedford, MA 01730 Duration: Perm Required Qualifications: Bachelor's degree in engineering, science or related field 6+ years of Systems Quality experience within a regulated enviornment (i.e., medical devices, aerospace or automotive) Experience with medical device regulations & standards such as ISO 13485 & ISO 14971 Experience with CAPAs, audits, risk management/remediation, management review, supplier audits, compliance, and quality agreements Broad knowledge of engineering and science principles, including R&D, quality control, manufacturing, and design engineering Quality Management Techniques: Lean Six Sigma, Statistical methods to measure changes Product Knowledge: IL products, technology, and manufacturing processes, Impact on customers and patients Regulatory Compliance: Application of regulatory requirements to data review, reports, design changes, risk management , risk-based approach to processes and decisions Preferred Qualifications: 5 years of experience with an advanced degree Knowledge of medical device regulations (e.g., FDA QSR, EU MDR) and standards (e.g., IEC 62304, IEC 62366, AAMI TIR57). Day-to-Day: An employer is looking for a Sr. Systems Quality Engineer role in Bedford, MA involves leading the development of medical diagnostic systems. Key responsibilities include: Research, design, and development of specific parts, processes, software, or components. Integration of hardware into full systems with software and firmware. Configuration management, requirements engineering, risk management, and verification Technical leadership for specific projects, ensuring completion of deliverables according to schedules Documentation and design control activities Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Quality Assurance Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Insight Global by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Get notified about new Quality Engineer jobs in Bedford, MA . Marlborough, MA $75,000.00-$85,000.00 1 week ago Marlborough, MA $77,900.00-$110,400.00 2 weeks ago Bedford, MA $115,000.00-$145,000.00 1 week ago Bedford, MA $100,000.00-$200,000.00 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 Insight Global