Senior Quality Engineer — Path to Quality Manager

Rise Technical; Detroit (MI); On-site; USD 110,000 - 115,000; Full time

Benefits offered by this job

Profit Sharing

Training

Tuition Reimbursement

Progression to Quality Manager

8am-4pm hours

Job summary

Rise Technical seeks a Senior Quality Engineer for a medical FDA-regulated environment near Detroit, MI. On offer is a permanent on-site role with progression to Quality Manager, tuition reimbursement, and ongoing development. Salary $110,000-$115,000 + profit sharing, with 8am-4pm hours and training opportunities.

You will lead CAPA and non-conformance investigations, support audit readiness, and drive IQ/OQ/PQ and risk management documentation in line with ISO 13485 and 21 CFR 820.

Qualifications

• Quality Engineering experience in a regulated manufacturing environment (ISO 13485 and/or 21 CFR 820).
• CAPA / root cause experience (5 Whys, 8D, Fishbone, DMAIC) and data/statistical tools (MSA, Gage R&R, Cp/Cpk, Minitab).
• Bachelor’s degree in Biomedical, Aerospace or Mechanical Engineering (or foreign equivalent).

Responsibilities

• Lead non-conformances, CAPA, SCAR and customer complaints, including root cause and corrective actions.
• Support QMS development (procedures, work instructions, document control) and internal audits.
• Drive validation and risk management documentation (IQ/OQ/PQ, pFMEA, control plans, process flow diagrams).

Skills

CAPA / root cause analysis

Regulated QA experience

Data / statistical tools

Education

Biomedical, Aerospace or Mechanical Eng

Tools

Minitab

MSA

Gage R&R

Cp/Cpk

Job description

Rise Technical seeks a Senior Quality Engineer for a medical FDA-regulated environment near Detroit, MI. On offer is a permanent on-site role with progression to Quality Manager, tuition reimbursement, and ongoing development. Salary $110,000-$115,000 + profit sharing, with 8am-4pm hours and training opportunities.

You will lead CAPA and non-conformance investigations, support audit readiness, and drive IQ/OQ/PQ and risk management documentation in line with ISO 13485 and 21 CFR 820.