Overview
Entry Level Quality Assurance Engineer (Hybrid role) Jobs in Mahwah, NJ at Radiant Systems Inc
Title: Entry Level Quality Assurance Engineer (Hybrid role)
Company: Radiant Systems Inc
Location: Mahwah, NJ
We are hiring Entry Level Quality Assurance Engineer (Hybrid role).
Please let me know if you are interested or anyone who might be interested.
Client: Major Medical Device Client
Position: Entry Level Quality Assurance Engineer (Hybrid role)
Duration: 12+ Months Contract
Location: Mahwah, NJ 07430
Pay Rate: $30.00-$38.00/ Hr on W2
***THIS IS A MANUFACTURING QA ROLE, NOT IT. IT EXPERIENCE WILL NOT BE CONSIDERED***
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Description:
First Shift, 8AM – 5PM
Hybrid (min. of 3 days on site)
MUST HAVES:
- Great problem solving and critical thinking skills (1+)
- Able to independently use engineering rationale make decisions (1+)
- Knowledge/Experience with Validation (1+)
- Bachelor’s Degree in Engineering field
NICE TO HAVES:
- Experience developing or approving SOPs
- Great communication skills
- Ability to follow a timeline and track deliverables
- Self-starter
Any questions we can ask specifically before submitting to save you time?
- Have you ever worked for a medical device company?
- Any experience working on a project where new process was implemented?
- Have you worked with landing new manufacturing equipment and qualifying/validating it?
- Have you worked on other projects with timelines?
Job Details:
As a Quality Engineer, you will provide quality engineering support in quality assurance, control, and preventative activities within operations and other business functions.
You will be tasked with developing and implementing methods and procedures for process control, process improvement, testing, and inspection to ensure that products are free of flaws and function as designed.
You will be expected to support:
- Validation projects for new equipment and processes introduced to the plant.
- First Article Inspection (FAI) strategy development, execution, and approvals.
- Standard Operating Procedures (SOP) and Inspection Plan creation and updates through the change management system.
- And more.
Additional Details:
- You will collaborate with the Manufacturing Engineering team, Sterility Assurance Teams, and Design Teams to land new equipment and set up the process for quality and compliance success by implementing appropriate, risk-based process controls and equipment maintenance measures.
- This is an individual contributor role that requires the use of judgment in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. The job requires an understanding and application of procedures and concepts of the discipline. The role requires the ability to make judgments based on practice and previous experience.
- You will advocate and lead the execution of initiatives and projects to enhance quality performance within the business and ensure compliance with regulations and standards.
Expected Qualifications:
- Bachelor’s Degree in Biomedical Engineering, Mechanical Engineering, or a related field.
- 1+ years of industry experience required.
- Knowledge of Change Management and Quality Management Systems (QMS) principles.
- Firm understanding of medical device concepts is highly desirable.
- Familiarity with ISO 13485, GDP, and GMP concepts is highly desirable.
- Excellent communication skills and attention to detail.
- Good understanding of engineering and quality concepts/theories.
- High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel, and PowerPoint.
- Self-starter with an efficient work style and the ability to handle multiple tasks in a fast-paced environment.
- Willingness to work as part of a multi-site team.
- Knowledge of risk-based and statistical concepts is desirable.
- Strong problem-solving and analytical skills.
- Ability to build strong relationships by fostering open communication, respect, and trust. Strong team player with a customer service and stakeholder-focused approach.
- Ability to be the voice of Quality when working cross-functionally.
- Excellent English communication skills (both written and verbal).
- Up to 10% travel may be required.
Regards
Vishnu Das Natesan
