Sr. Systems Quality Engineer

Insight Global

Bedford (MA)

On-site

USD 120,000 - 145,000

Full time

14 days+

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Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

Join a forward-thinking company as a Sr. Systems Quality Engineer, where you will play a pivotal role in the development of medical diagnostic systems. This exciting position involves leading projects, ensuring compliance with medical device regulations, and applying quality management techniques to enhance product integrity. You will collaborate with cross-functional teams to integrate hardware and software, manage risk, and drive technical excellence. If you are passionate about quality assurance in the medical equipment industry and have a strong background in systems quality, this is the perfect opportunity for you to make a significant impact.

Qualifications

6+ years of Systems Quality experience in a regulated environment.
Knowledge of ISO 13485 & ISO 14971 regulations.
Experience with CAPAs, audits, and risk management.

Responsibilities

Lead development of medical diagnostic systems.
Ensure completion of deliverables according to schedules.
Manage documentation and design control activities.

Skills

Systems Quality

Quality Management Techniques

Lean Six Sigma

Statistical methods

Regulatory Compliance

Education

Bachelor's degree in engineering, science or related field

Advanced degree

Job description

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