Sr. Quality Engineer — Medical Devices, CAPA & Audits

Hydrogen Group; Saint Paul (MN); On-site; USD 120,000 - 170,000; Full time

Job summary

Hydrogen Group seeks a lead quality engineer for a manufacturing site in Minnesota. You will set the technical direction for Manufacturing, Engineering, Operations and Quality, leading investigations, validations, risk assessments and continuous improvement efforts.

You will author and approve essential quality documentation and mentor the team while taking a front-line role in audits with customers, suppliers and regulators.

Qualifications

• Bachelor's degree in Life Science or technical discipline.
• 7+ years in quality engineering or QA in regulated manufacturing (medical devices, biotech, pharma).
• Working knowledge of ISO 13485 and FDA 21 CFR Part 820/QMSR.
• Strong statistical skills using Minitab (process capability, DOE, hypothesis testing, sampling plans).
• Experience leading CAPA, nonconformance, validation and change control from start to finish.
• Strong technical writing and ability to defend conclusions to customers, auditors and leadership.

Responsibilities

• Set the technical direction for Manufacturing, Engineering, Operations and Quality.
• Lead complex investigations, validations, risk assessments and continuous improvement work.
• Author and approve key quality documentation.
• Mentor the team and perform audits with customers, suppliers and regulators.

Skills

Quality leadership

CAPA management

Statistical methods

Regulatory knowledge

Risk assessment

Documentation writing

Education

Bachelor's degree in Life Science or technical discipline

Tools

Minitab

Job description

Hydrogen Group seeks a lead quality engineer for a manufacturing site in Minnesota. You will set the technical direction for Manufacturing, Engineering, Operations and Quality, leading investigations, validations, risk assessments and continuous improvement efforts.

You will author and approve essential quality documentation and mentor the team while taking a front-line role in audits with customers, suppliers and regulators.