Quality Engineer

Quality Engineer

$90,000 - $100,000 + Training (Tuition Reimbursement / Certifications / Udemy) + Technical Progression to Senior + Long-Term Development + 8am-4pm Schedule

Clinton Township, MI (Commutable from: Sterling Heights, Warren, Roseville, Mount Clemens, Fraser, St Clair Shores, Detroit)

Are you a Quality Engineer or Senior Quality Engineer with regulated manufacturing experience, looking for a role where you can deepen your validation and risk expertise and progress into a senior-level position with a business that promotes from within?

On offer is a permanent, on-site position with long-term development, supported training (tuition reimbursement, certifications and Udemy upskilling) and a clear pathway to step up into a senior role as you take ownership of key quality and compliance activities.

This company is an established North American manufacturer known for supporting internal progression and investing in its people. As a result of continued demand across its markets, they are looking to add an additional Quality Engineer to strengthen site quality and customer compliance support.

In this role you will lead validation documentation (plans, protocols, reports), support risk assessments (ISO 14971 / FMEA), conduct internal audits to ISO 13485 and FDA 21 CFR Part 820, and drive corrective / preventive actions and continuous improvement across production quality systems.

This role would suit a Quality Engineer looking for technical development, increased responsibility and a genuine route into a senior position within a stable, growing organization.

The Role:
- Validation activities: plans, protocols, issue resolution and client submissions
- Risk analysis and assessments (ISO 14971 / FMEA) and quality planning
Internal audits for ISO 13485:2016 and FDA 21 CFR Part 820 compliance
- CAPA / NCR investigation and continuous improvement of quality processes
- On-site role in Clinton Township, MI (8am-4pm schedule)

The Person:
- Degree in Engineering, Life Sciences, or a related field
- Knowledge of ISO 13485 and FDA 21 CFR Part 820 (regulated quality experience)
- Experience with validation / risk / production quality systems (SPC, Gage R&R, disciplined problem solving)

Reference Number: BBBH280957

To apply for this role or to be considered for further roles, please click "Apply Now" or contact Ewart Grogono-Thomas at Rise Technical Recruitment.

Rise Technical Recruitment Inc of 1011 Centre Rd, Suite 322, Wilmington, DE 19805 act as an employer-paid private personnel agency.

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.