Senior Quality Engineer

Rise Technical; Clinton Charter Township (MI); On-site; USD 105,000 - 115,000; Full time

Benefits offered by this job

Profit Sharing

Training

Tuition Reimbursement

Progression to Quality Manager

Regular hours 8am-4pm

Job summary

Rise Technical Recruitment Ltd is recruiting for a Senior Quality Engineer in Michigan. The role pays $105,000–$115,000 annually plus profit sharing, training and tuition reimbursement, with a clear path to Quality Manager as the site grows.

You will lead CAPA, non-conformances, supplier corrective actions, audits and documentation control, and drive IQ/OQ/PQ validation and risk management in line with ISO 13485 and 21 CFR 820.

Qualifications

• Experience leading CAPA/non-conformance investigations in regulated manufacturing.
• Experience with IQ/OQ/PQ validation and risk management documentation.
• Familiarity with ISO 13485 and 21 CFR 820 requirements.

Responsibilities

• Lead non-conformances, CAPA, SCAR and customer complaints with root cause actions.
• Support QMS development, procedures and document control for audits.
• Drive validation and risk management activities per ISO 13485/21 CFR 820.

Skills

CAPA/root cause analysis

Data analysis

Leadership potential

Education

Bachelor’s degree in Biomedical, Aerospace or Mechanical Engineering (or foreign equivalent)

Tools

MSA

Gage R&R

Cp/Cpk

Minitab

Job description

$105,000 - $115,000 + Profit Sharing Bonus + Training + Tuition Reimbursement + Progression to Quality Manager + 8am-4pm Hours

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

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