Sr. Quality Engineer / Principal Quality Engineer – Medical Device –

Company: MR-MRI-North Naples ( Learn More )

General Information
US-NJ-Parsippany-Troy Hills
$70,000.00 - $85,000.00 /Year
4 Year Degree
At least 4 year(s)
Not Specified
Job Description

Location: Parsippany, NJ

The Company: Investing in people. Dynamic Growth. Invested in advancing your career.

Does a fast-paced wide-ranging job, where every day will look different than the one before, excite you?  Growing mid-tier Medical Device Company with strong financial stability is making significant investments in growing US operations. True career advancement awaits the right professionals - employee focused management, facility investments, new product launches…and did I mention dynamic growth?  Humongous, exciting, let’s all stand up and cheer kind of GROWTH.


The Challenge: Very soon they will be growing TOO FAST.  We need a Sr. Quality Engineer who will make an immediate impact by helping streamline quality operations and maximizing work flow efficiencies within the entire Life Cycle - from New Product Development, to Design, to Launch, through Manufacturing, Supplier Management, and all CAPA / post market monitoring and safety issues. 

Having a small company feel we are seeking someone that can thrive in a high paced environment where having a hands-on “I’ll find a way to get it done" mentality will propel your success and career.  Areas of specific focus will include: developing, implementing and overseeing the processes and practices that will ensure on-going compliance for global medical device standards and regulations, overseeing continuous improvement initiatives utilizing Lean Six-Sigma, quality assurance, NPD / new product development quality support, providing root-cause analysis and corrective / preventative actions, overseeing all design assurance activities, design controls and reviews, design and process – as well as test method - verification and validations, quality planning, process controls, product assurance plans, conducting both internal and external audits, support  the consolidation of the global QMS, overseeing Engineering Change Orders, and providing MRB support.

Job Requirements

Experience, Education and Work History:

  • BS in Engineering highly preferred – other science based technical degrees will be considered
  • Minimum of 4 years of Quality experience supporting Medical Device Manufacturing Operations
  • FDA / ISO 13485 expertise is absolutely required
  • ASQ certified Quality Auditor and/or Quality Engineer - CQE, CRE, PE, CRA and/or Lean Six Sigma Certifications are highly desirable

Compensation: Base salary in the $70,000 - $85,000 range plus bonus, benefits and much more!

Three simple steps for consideration: 

1. Connect with Micah Di Sabato on LinkedIn
2. Submit your resume to [Click Here to Email Your Resumé]
3. Enjoy the benefits of joining my LinkedIn group: Medical Device Premiere Talent to network with the movers & shakers of the industry!