A Senior Quality Engineer for a medical devices and equipment manufacturing company is needed in the Portage, MI area. The Quality Engineer ensures product and process compliance by leading quality assurance efforts, risk management, design control, and integration activities across cross-functional teams using QMS tools and standards.
location: Portage, Michigan
job type: Contract
salary: $64.28 - 75.00 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Develops and implements methods for process control, improvement, testing, and inspection to ensure products meet design and quality standards.
- Designs and installs sophisticated testing equipment, performs product testing and analysis to minimize defects and failures.
- Analyzes defect reports and product issues, identifies trends, and recommends corrective actions.
- Collaborates with suppliers to resolve quality issues and contribute to supplier quality improvement programs.
- Works independently with minimal supervision, applying professional judgment and discipline-specific concepts.
- Participates in QMS activities to support integration of new acquisitions.
- Reviews product artifacts, drives process and product changes via change control.
- Interfaces with Regulatory, QA, and R&D teams for integration projects.
- Leads and executes through the design control process using both existing and new procedures.
- Conducts and drives requirements reviews, V&V, CSV, and design documentation.
- Performs safety risk assessments (e.g., sFMEA, Risk Plans).
- Supports release management and DevSecOps compliance processes.
- Creates or reviews SOPs, work instructions, and forms.
- Requires a university degree or equivalent and
- 2+ years of experience in a related field.
qualifications:
- Experience level: Experienced
- Education: Bachelors
skills:
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.
