If you have a background in quality engineering, experience with ISO standards, and a drive for continuous improvement, we want to hear from you!
salary: $80,000 - $90,000 per year
shift: First
work hours: 7 AM - 4 PM
education: Bachelors
Responsibilities
- Support the maintenance of the Quality Management System (QMS) to ensure compliance with industry standards and regulatory requirements, including ISO certifications and FDA guidelines.
- Develop, revise, and review Standard Operating Procedures (SOPs), Work Instructions (WIs), and related documentation to ensure consistent compliance with industry standards.
- Promote the use of risk management and reduction tools, such as Failure Mode Effects Analysis (FMEA), to mitigate potential issues.
- Participate in internal audits as a member of the audit team, ensuring adherence to regulatory standards.
- Analyze Statistical Process Control (SPC) charts to monitor product and process performance, especially for new products.
- In-depth knowledge of regulatory standards such as FDA QSR, ISO 13485, and ISO 14971.
- Prepare and submit required documentation for customer-specific needs, including PPAP and process qualifications (IQ/OQ/PQ), for new product or process introduction.
- Validate internal data and processes before commercializing new or modified products and processes.
- Ensure Test Method Validation (TMV) processes are maintained for repeatable and predictable testing.
- Conduct analysis of Gage R&R studies and inter-laboratory comparisons as required by industry standards and customer specifications.
Skills
Qualifications
Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad.
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 health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
