Senior Quality Engineer (Design QA) Job

Employer
Merck
Location
Whitehouse Station, NJ, US
Posted
October 12 2017
Organization Type
Pharma
Requisition ID: QUA006220

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.



Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. 


 


The primary purpose of this position is to provide Device QA support and leadership to ensure sustaining/remediation activities and successful quality oversight of prospective combination products. This individual will be expected to apply his/her knowledge of product development, design control principles, and quality engineering techniques to positively influence commercial and new product launches to ensure they are developed and manufactured in accordance with regulatory, company, and customer requirements. Will review and evaluate scientific and technical data as it pertains to product and product testing and lead teams to identify and solve complex product problems.

Qualifications

Education Minimum
Requirement:



  • A Bachelor’s degree
    in (Science or Engineering or associated fields) with a minimum of 7 years
    related experience OR a Master’s degree (Science or Engineering or associated
    fields) and 5 years related experience OR a Ph.D. (Science or Engineering or
    associated fields) and 3 years of related experience. Advanced degrees may be
    used reduce required experience.


 

Required Experience
and Skills:
  



 

Knowledge/experience with quality
tools:



  • Design Controls /
    CAPA / Purchasing Controls
  • Risk analysis (ICH Q9
    and/or ISO 14971)
  • Medical Device &
    Combination Product regulations (ISO 13485/11608, IEC 62304, 21CRF part 820,
    210/211)
  • Have demonstrated
    ability to work collaboratively in cross functional teams and networks; able to
    foster cooperation in others.
  • Be an effective
    communicator and working knowledge of device development and commercialization,
    product approval, and/or regulatory inspection experience with the medical
    device constituent of a combination product.
  • High proficiency with
    Microsoft Word, Microsoft Excel, Power Point and statistical tools (e.g.,
    Minitab or Sigma XL) is required. Strong technical writing skills are required.
  • Technical expert
    working independently, and have excellent interpersonal relationship skills
    with flexibility to adapt to fast pace environment with changing priorities


 

Preferred Experience
and Skills:



  • Experience in the use
    of root cause analysis and applied statistical techniques
  • Certified Lean Six
    Sigma Green Belt or Black Belt and/or Certified Quality Engineer (CQE) or
    reliability engineer (CRE) are strongly desired.


 

Your role at Merck is
integral to helping the world meet new breakthroughs that affect generations to
come, and we’re counting on your skills and inventiveness to help make
meaningful contributions to global medical advancement. At Merck, we’re
inventing for life. 



 

If you need an
accommodation for the application process please email us at
staffingaadar@merck.com.



  

Search Firm
Representatives Please Read Carefully: 



Merck & Co., Inc. is
not accepting unsolicited assistance from search firms for this employment
opportunity.  Please, no phone calls or emails.  All resumes
submitted by search firms to any employee at Merck via email, the Internet or
in any form and/or method without a valid written search agreement in place for
this position will be deemed the sole property of Merck.  No fee will be
paid in the event the candidate is hired by Merck as a result of the referral
or through other means.



 



Job: Quality Engineering
Other Locations:
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck