Quality Engineer

Job Title: Quality Engineer

Location: Plymouth, MN, USA

Experience: 5 - 8 Years

Duration: 12+ Months Employment Type: Contract

Industry: Healthcare

Must-Have Skills / Attributes

Audit

GMP

Medical Device

Quality Engineer

Education

Required: Bachelor’s degree in Engineering, Quality Management, or related technical field

Preferred: Advanced certifications (e.g., ASQ Certified Quality Engineer, Auditor Certification)

Experience

Required:

Minimum 5 years performing internal audits for medical device QMS compliance

Hands-on experience with internal and external audits in a regulated environment

Strong knowledge of 21 CFR 820, ISO 13485, and cGMP requirements

Experience reviewing and approving product and QMS documentation

Proven track record in maintaining audit schedules and generating audit reports

Strong communication skills for scheduling audits and reporting findings

Ability to manage multiple priorities in a fast-paced environment

Preferred:

Experience in medical device or pharmaceutical industries

Proficiency with QMS software/tools

Key Responsibilities

Maintain and ensure compliance with QMS requirements

Review product and QMS documentation for regulatory compliance

Develop, manage, and maintain the internal audit schedule

Assist in preparing audit agendas and coordinate audit logistics

Conduct internal audits and generate audit reports

Review and approve work products related to QMS and product compliance

Support general Quality Engineering activities as needed