Sr. Systems Quality Engineer

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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.

$/yr - $/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 TIR
  57).

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
  
  Mid-Senior level

• Employment type
  
  Full-time

• Job function
  
  Quality Assurance
• Industries Medical Equipment Manufacturing

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