Quality Assurance Engineer

job summary:

Advance healthcare and build life-changing technology with an industry leader by joining our client as a Quality Assurance Engineer in Portage, MI. We are seeking candidates with a Bachelor's degree and 0-2 years of experience in ISO 13485/GMP environments to drive compliance, lead quality improvements, and uphold world-class medical standards.

location: Portage, Michigan job type: Contract salary: $42 - 52 per hour work hours: 8am to 5pm education: Bachelors

responsibilities:

• Manage non-conformances (NCs) and Corrective/Preventive Actions (CAPAs) through root cause analysis, supplier communication, and cross-functional problem-solving.
• Support process and equipment validations, Measurement System Analysis (MSA), change management activities, and risk management practices.
• Monitor quality performance using statistical tools and key performance indicators (KPIs) to identify trends and implement continuous improvements.
• Provide quality assurance representation during internal/external audits, manufacturing transfers, containment plans, and Quality Acceptance Tests (QATs).
• Collaborate with Operations, suppliers, and multi-site teams to ensure strict compliance with regulatory standards, ISO 13485, GDP, and GMP concepts.

qualifications:

Bachelor's degree in engineering or a related technical field with 0-2 years of experience in a Quality or Regulatory Affairs role.

Working knowledge of ISO 13485, GDP, and GMP concepts, along with familiarity with risk management, statistics, and CAPA principles.

Strong analytical, communication, and problem-solving skills with a continuous improvement mindset and the ability to thrive in a fast-paced team environment.

skills:

equipment validation,Excel,PowerPoint,Proficient in Microsoft Word,analytical,attention to detail,Communicate,communications,communication skills,Confident,tactful,Diplomatic,interpersonal skills,Strong problem-solving,proactive,Self-starter,Team player,Acceptance Tests,internal and external audits,Audits,continuous improvement,Change Management,open communication,continuous improvement mindset,Corrective and Preventive Actions,CAPAs,Corrective Action,corrective actions,CAPA,ISO 13485,statistical methods,Statistics,statistical concepts,Lean principles,waste elimination,manufacturing,manufacturing processes,Measurement System,process risk,process analysis,quality control,Quality Assurance,quality processes,process quality,QA,quality principles,Regulatory Affairs,ensure compliance,risk,risk management practices,risk management,root cause analysis,standardization,identify trends,supplier relationships

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.