Medical Device Quality Engineer - ISO 13485 Focus

Keystone Manufacturing, Inc.; Oshtemo Charter Township (MI); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Comprehensive medical coverage

Dental and vision options

Life insurance

Short term disability

Long term disability

Retirement savings plan with company 1

Paid Time Off and holidays

Job summary

Keystone Manufacturing, Inc. in Kalamazoo, MI seeks a Quality Engineer to develop and maintain quality standards for medical devices. The role involves root cause analysis, external complaints handling, and continuous improvement of the QMS.

The candidate should have a bachelor’s degree in engineering and at least 2 years in a regulated setting, with ISO 13485/GMP familiarity. Strong documentation and teamwork are essential for success in this fast-paced environment.

Qualifications

• Bachelor’s degree in engineering or related field.
• Minimum of 2 years’ experience in a regulated manufacturing environment.
• Familiarity with ISO 13485, QSR and GMP requirements.
• Authorized to work in the US without sponsorship.
• Ability to interpret SOPs and customer specifications.
• Experience with sterile barrier packaging and clean room is a plus.

Responsibilities

• Supports development of new product lines ensuring quality principles.
• Investigates external complaints and internal non-conformances; drives improvements.
• Participates in external audits (FDA, ISO) and training on QSR/ISO topics.
• Conducts internal audits and maintains Keystone QMS compliance.
• Reviews and approves SOPs aligning with regulatory requirements.
• Maintains relationships with Production, Quality, and Regulatory affairs.
• Performs product sampling and ships samples as requested.
• Assists with root cause analysis for NCRs, CARs, and complaints.

Skills

calipers

rulers

micrometers

Education

Bachelor’s Degree in Engineering

Tools

Measurement equipment

Job description

Keystone Manufacturing, Inc. in Kalamazoo, MI seeks a Quality Engineer to develop and maintain quality standards for medical devices. The role involves root cause analysis, external complaints handling, and continuous improvement of the QMS.

The candidate should have a bachelor’s degree in engineering and at least 2 years in a regulated setting, with ISO 13485/GMP familiarity. Strong documentation and teamwork are essential for success in this fast-paced environment.