Supplier Quality Engineer: Risk, Audits & Compliance

Laborie; Portsmouth (NH); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Paid time off

Medical, Dental, Vision

HSA with company contributions

401k with company match

Parental Leave

Wellness programs

Job summary

Laborie is seeking a Supplier Quality Engineer to manage risk and quality systems for suppliers and contract manufacturers. You will audit suppliers, drive corrective actions, and support QA processes across development projects.

Ideal candidates hold a engineering-related degree with 5+ years in quality assurance and solid knowledge of ISO 13485 and 21 CFR. This role emphasizes cross-functional collaboration and quality improvement.

Qualifications

• Bachelors degree in engineering or related field and 5+ years in quality assurance.
• Experience with ISO 13485 and 21 CFR compliant systems.
• Auditing experience, internal and external.
• Experience applying statistical methods to QA.
• Must review Training Matrix Q620-FRM-03 or equivalent.

Responsibilities

• Identify and manage risks with supplied materials and quality system procedures.
• Use risk tools to identify and mitigate supplier risks and support supplier selection.
• Audit current/future suppliers for quality system compliance and material specs.
• Issue supplier corrective actions and monitor KPI reports.
• Support QA processes: internal audits, complaint handling, CAPA.
• Participate in product design projects and provide engineering risk management.

Skills

Quality Assurance

Auditing

Risk Management

Statistical Methods

Supplier Management

Education

Bachelor's degree in engineering or related field

Job description

Laborie is seeking a Supplier Quality Engineer to manage risk and quality systems for suppliers and contract manufacturers. You will audit suppliers, drive corrective actions, and support QA processes across development projects.

Ideal candidates hold a engineering-related degree with 5+ years in quality assurance and solid knowledge of ISO 13485 and 21 CFR. This role emphasizes cross-functional collaboration and quality improvement.