Senior Quality Engineer

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

Senior Quality Engineer / Medical FDA regulated environment

$110,000 - $115,000 + Profit Sharing Bonus + Training + Tuition Reimbursement + Progression to Quality Manager + 8am-4pm Hours

Site near Detroit, MI - (Commutable from: Sterling Heights, Warren, Roseville, Macomb, Mount Clemens, Clinton Township, Troy, Royal Oak)

Are you a Quality Engineer looking to step into a senior role with a clear route into management, where you can take real ownership of CAPA, non-conformances and customer quality?

On offer is a permanent, on-site position with a well-established manufacturer where you will be backed with ongoing development (tuition reimbursement, certifications and Udemy) and given the platform to progress into a Quality Manager position as the site continues to grow.

Established in 1980 with multiple North American plants, this business is known for producing high-quality plastic components across regulated and high-expectation markets. Due to continued growth, they are now looking to add a Senior Quality Engineer to strengthen their quality function.

In this role you will lead non-conformance investigations, CAPA and supplier corrective actions, support audit readiness and document control, and drive validation activity (IQ/OQ/PQ) and risk management documentation in line with ISO 13485 and 21 CFR 820.

This role would suit a Quality Engineer with ISO 13485 / 21 CFR 820 experience, looking to take on more responsibility, develop leadership skills and progress into management long-term.

The Role:

• 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)

The Person:

• 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)

Reference Number: BBBH280956

The salary advertised is the bracket available for this position. The actual salary paid will be dependent on your level of experience, qualifications and skill set and will be decided by our client, the employer. Rise are not responsible or liable for any hiring decisions made by the end client.

We are an equal opportunities company and welcome applications from all suitable candidates.