quality engineer .

We are seeking a Quality Engineer to join our team and play a key role in ensuring compliance with ISO 9001, ISO 13485, FDA QSR, and ISO 17025 standards. This role is ideal for a detail-oriented professional with experience in quality systems, process improvement, and medical device regulations.

Key Responsibilities:

• Maintain and improve the Quality Management System (QMS) to meet ISO and FDA requirements.
• Develop, revise, and review Standard Operating Procedures (SOPs), Work Instructions (WIs), and Form Control Documents (FCDs).
• Conduct internal audits and lead risk analysis initiatives (FMEA, etc.).
• Analyze SPC charts and prepare PPAP, IQ/OQ/PQ for product/process validation.
• Ensure compliance with Device Master Records (DMR) and Device History Records (DHR).
• Manage customer feedback, complaints, and Return Material Authorization (RMA).
• Serve as Recall Coordinator, leading mock and official recall activities.
• Promote a culture of continuous improvement (Kaizen) and participate in root cause analysis sessions.

Qualifications:

• Bachelor’s degree in Applied Mathematics, Engineering, or a related field (or 10 years of experience in lieu of degree).
• 2-5 years of quality engineering experience in the medical device industry.
• Proficiency in Minitab, Excel, Access, PowerPoint, and Word.
• Knowledge of FDA QSR, ISO 13485, and ISO 14971 regulations.
• Experience with Test Method Validation (TMV), CAPA, and non-conformance management.
• strong leadership and communication skills.

Join our team and contribute to the development of high-quality medical devices that improve lives.



salary: $80,000 - $95,000 per year
shift: First
work hours: 8 AM - 5 PM
education: Bachelors

Responsibilities

• Assist in maintaining QMS in 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.
• Champion use of risk analysis and reduction tools (FMEA, etc).
• 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.
• Establish and maintain Device History Records (DHR) that meet all FDA requirements.
• Maintain customer feedback and complaint records per ISO9001, ISO13485, and FDA requirements.
• Provide information on Return Material Authorization (RMA) from customer complaints

The essential functions of this role include:

wearing steel toe shoes

Skills

Quality Assurance

Quality Control

Product Inspection

First Yield Pass

Disassembly

Reassembly

Sampling

Testing

Inspection

Production Control

Monitoring

Providing Feedback

Blueprints

Sorting

Supervising

Leading

Influencing

Qualifications

Years of experience: 3 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.