Senior Quality Engineer

Insight Global; Salt Lake City (UT); On-site; USD 110,000 - 150,000; Full time

Job summary

Insight Global seeks a Senior Quality Engineer to support new product development and sustaining activities in a regulated medical device setting. You will serve as the Quality representative on cross-functional teams, ensuring lifecycle compliance from concept to commercialization.

The role emphasizes design controls, risk management, product validation, statistical analysis, quality systems, and regulatory adherence, collaborating with engineering, suppliers, vendors, and customers to meet

Qualifications

• Bachelor's Degree in Mechanical or Biomedical Engineering.
• 5-8 years of Quality Engineering experience.
• Medical Device industry experience.
• Design Controls: Design Verification, Validation, Transfer, Inputs/Outputs.
• Experience with Minitab and interacting with vendors and customers.

Responsibilities

• Review design documentation and participate in risk reviews.
• Analyze test results and support audits.
• Collaborate with suppliers, vendors, and customers to ensure compliance.
• Approve engineering changes and support product lifecycle from concept to commercialization.

Skills

Quality Engineering

Design Controls

Risk Management

Statistical Analysis

Minitab

Vendor Interaction

Product Validation

Regulatory Compliance

Cross-functional Collaboration

Engineering Change Control

Education

Bachelor's Degree in Mechanical Engineering

Bachelor's Degree in Biomedical Engineering

Tools

Minitab

Job description

Insight Global is seeking a Senior Quality Engineer to support new product development and sustaining engineering activities within a regulated medical device environment. This individual will serve as the Quality representative on cross-functional product development teams and ensure compliance throughout the product lifecycle from concept through commercialization. The ideal candidate will have strong experience with design controls, risk management, product validation, statistical analysis, quality systems, and medical device regulations. This role requires collaboration with engineering teams, suppliers, vendors, and customers to ensure products meet performance, quality, and regulatory requirements. They will spend time reviewing design documentation, participating in risk reviews, analyzing test results, working with suppliers, supporting audits, and approving engineering changes.

Required Skills & Experience:

• Bachelor's Degree in Mechanical Engineering OR Biomedical Engineering
• 5-8 years of Quality Engineering experience
• Medical Device industry experience
• New Product Development support
• Design Controls experience - Design Verification, Validation, Transfer, Inputs/Outputs
• Experience with Minitab or equivalent Experience interacting with vendors and customers
• BS in Mechanical or Biomedical
• BS in Mechanical or Biomedical

Nice to Have Skills & Experience

• ASQ Certified Quality Engineer (CQE)
• Lean Six Sigma

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [e-mail]. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.