Job Posting: Quality Assurance Engineer - Adecco (Parsippany, NJ)
Job Summary:
Adecco is hiring for a Quality Assurance (QA) Engineer in the Parsippany, NJ area. In this role, you will play a pivotal part in the implementation of a Surgical's Quality Management System (QMS), gaining hands-on experience across a range of quality functions related to ISO 13485 and 21 CFR Part 820 compliance. The QA Engineer will be responsible for managing complaint handling, product release procedures, and supporting NCR and CAPA processes, while developing strong relationships with suppliers. This position also offers an opportunity to work with cross-functional teams in ensuring regulatory compliance during product development and technical file development.
Responsibilities:
Receive, document, and process complaints related to product quality and patient safety.
Conduct, coordinate, and document complaint investigations.
Review complaints for possible Adverse Events (AEs)/Medical Device Reports (MDRs) and recommend regulatory reporting decisions. Prepare reports to regulatory agencies in a timely manner.
Review and approve Device History Records (DHRs), ensuring compliance with Quality Agreements and QMS procedures, in collaboration with contract suppliers.
Participate in and support NCR (Non-Conformance Report) and CAPA (Corrective and Preventive Actions) investigations.
Apply statistical methods to trend NCRs, CAPAs, complaints, and DHR approval acceptance.
Support the supplier vetting process and maintain the Approved Supplier List.
Provide quality engineering support during design transfer and process validations for Product Development and Operations.
Participate in product risk assessment efforts, including conducting Failure Mode Effect Analysis (FMEA).
Monitor quality metrics and key process indicators to identify opportunities for improvement.
Lead or participate in multi-departmental initiatives for quality improvements.
Drive compliance to QMS and provide QMS training to team members.
Author changes to existing procedures, work instructions, and forms as needed.
Ensure compliance with U.S. FDA, ISO requirements, and other regulatory standards, in addition to company policies and procedures.
Assist in the review of Technical Files.
Perform other QA and quality control tasks as necessary, with appropriate training.
Requirements:
Minimum of 3 years of quality assurance experience in the medical device industry. Experience in manufacturing or supplier quality engineering is a plus.
Working knowledge of CFR Part 820 and ISO 13485 for medical device products.
Proven experience in complaint investigations.
A Bachelor’s degree in an engineering discipline.
Certified Quality Engineer (CQE) certification is a plus.
Experience in root cause failure analysis and change control processes.
Strong attention to detail and experience in a manufacturing environment are a plus.
Excellent verbal and written communication skills, including the ability to deliver presentations.
Pay Details: $38.00 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy
The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
- The California Fair Chance Act
- Los Angeles City Fair Chance Ordinance
- Los Angeles County Fair Chance Ordinance for Employers
- San Francisco Fair Chance Ordinance