qa specialist (latham, ny).

• latham , new york

• posted may 14, 2024

job details

summary

• $25 - $30 per hour

• contract

• no requirements

• category computer and mathematical occupations

• reference1052163

job details

job summary:

The QA Specialist - DHR Reviewer is a member of the Manufacturing Quality team within the Philips MRI magnet manufacturing facility in Latham, NY. This is an onsite role which ensures compliance with legal, regulatory and international standards as they to Latham's Quality Management System. This individual ensures Device History Records meet regulatory and internal requirements and provide adequate verification of compliance to the product's engineering specifications.

In this role you are responsible for:

• Reviewing and approving of executed DHR packages (electronic & paper record) and ensuring the data is in compliance with relevant specifications, parameters and tolerances in accordance with local procedures, regulatory requirements and international standards.

• Reviewing data recorded in the Manufacturing Execution System (MES) to ensure compliance with relevant specifications, parameters and tolerances in accordance with local procedures, regulatory requirements, and international standards.

• Identifying areas for improvement within DHR process and data collection to optimize execution and efficiency.

• Executing in-line DHR reviews to proactively identify risks or nonconformances.

• Identifying non-conformances and taking appropriate actions to correct issues through Non-conforming Process.

• Reviewing proposed or revised DHR data collects to ensure compliance with relevant specifications, local procedures, regulatory requirements and international standards.

• Supporting nonconformance investigations, as required, to drive root cause and corrective actions in Operations.

• Providing Quality Engineers with support and data, as needed, to improve Quality on manufactured products.

location: Latham, New York

job type: Contract

salary: $25 - 30 per hour

work hours: 8am to 4pm

education: No Degree Required

responsibilities:

• Technician Diploma or bachelor's degree in engineering science or equivalent work experience.

• 1+ years Quality Assurance experience in medical device or regulated industry, preferred.

• Proficient in Good Documentation Practices (GDP).

• General understanding of ISO 9001, ISO 13485, FDA CFR 21 part 820, and Good Manufacturing Practices (GMP).

• Must understand the concept of traceability (product, material, and calibration).

• strong communication skills including written, verbal and listening skills.

• strong organizational skills, ability to multi-task and effectively prioritize your workload.

• Microsoft office proficiency a must - specifically, Word, Excel, PowerPoint, Visio and Outlook.

• Direct experience using eQMS and ERP software (e.g., Trackwise, EtQ, SAP) desired.

qualifications:

• Experience level: Entry Level

• Minimum 1 year of experience

• Education: No Degree Required

skills:

• Manual QA TestingEqual 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 Digital, 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 Digital offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).Applications accepted on ongoing basis until filled.