quality assurance engineer.

Are you a detail-oriented professional with a passion for quality assurance and regulatory compliance? We're seeking a Quality Systems Specialist to join our team. In this role, you'll play a key part in maintaining and enhancing our Quality Management System (QMS) in alignment with ISO 9001-2015, FDA QSR, ISO 13485, and ISO 17025 standards. This is a full time permanent opportunity Monday-Friday ( On-site at the faciltiy Riverhead, NY)  85k-95k  If you have experience in developing SOPs, conducting internal audits, driving risk reduction initiatives, and ensuring seamless product and process compliance, this role offers an exciting opportunity to make a meaningful impact. Please schedule a time via the scheduler for more information or email Chamira directly to Chamira.rosario@randstadusa.com for more information. 

salary: $80,000 - $95,000 per year
shift: First
work hours: 8 AM - 4:30 PM
education: Bachelors



Responsibilities

• 2-5 years of experience in quality engineering within the medical device industry or 10 years in lieu of degree
• Assist in maintaining quality manangement system with compliance with ISO 9001-2015, FDA QSR, ISO 13485,  and ISO 17025 requirements
• Create, revise, and review procedures (SOP), work instructions (WI) and Form Control Documents (FCD) related to Quality process to maintain compliance with ISO and FDA requirements.
• Conduct internal audits, as a member of the internal audit team (ISO Requirement).
• Prepare and analyze SPC charts for product and process parameters for current and new medical products.
• Generate and submit PPAP, IQ/OQ/PQ or other customer requirements for robust management of change / new product or process introduction.
• Review and validate internal management of change data before new or changed product / process commercialization.
• Maintain Test Method Validation (TMV) process to ensure new test methods are repeatable and predictable.
• Provide analysis of data on Gage R&R and inter laboratory comparison experiments in accordance with requirements of ISO 17025 and customer requirements.
• Establish and maintain robust Device Medical Records (DMR) that meet all FDA requirements.
• Provide information on Return Material Authorization (RMA) from customer complaints
• Direct experience with Test Method Validation (TMV), Corrective and Preventive Actions (CAPA), and managing non-conformances.

Skills

• Quality Assurance
• Quality Control
• Product Inspection
• First Yield Pass
• Sampling
• Testing
• Engineering
• Leading
• Monitoring
• Production Control
• Inspection

Qualifications

• Years of experience: 4 years
• Experience level: Experienced

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.