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TFF Quality Engineer

A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.

 

This role does not offer sponsorship for work authorization.  External applicants must be eligible to work in the US.

 

Your role:

 

We are looking for an experienced Quality Engineer to join our team supporting Tangential Flow Filtration (TFF) device manufacturing in Jaffrey, NH. The world-class Jaffrey Manufacturing Center of Excellence is ISO 9001 and ISO 14001 Certified, practices Six Sigma principles and is an environmentally conscious facility focused on long term sustainability.

 

  • Provide guidance and support for TFF device manufacturing. This includes the evaluation of deviations / out of specification conditions, data trending, and leading quality investigations:  root cause analysis, corrective action plans and customer complaints.
  • Provide guidance and support for product and process changes by working with the cross-functional team to determine the implantation requirements based on applicable industry standards and regulations.
  • Provide guidance and support for product validation and equipment qualifications including establishing acceptance criteria, sampling plans and performing data analysis.
  • Write or approve validation protocols and reports.
  • Create or revise Standard Operating Procedures, Test Methods and other documents.
  • Maintains compliance to ISO 9001 and QSR (cGMP) for medical devices
  • Perform statistical analysis and trending to assess and monitor product or process performance.
  • Provide guidance and approve the disposition of non-conforming product and raw materials.
  • Lead and participate in the creation of risk assessments (e.g. design and process FMEA).
  • Provide guidance and support for shelf life studies both accelerated and real-time aging, including protocol creation, sample submission, data analysis, out of specification investigation, and report creation.

 

Who you are:

 

Minimum Qualifications:

  • Bachelor of Science in Engineering or related discipline.
  • 1+ years Quality Engineering experience in a FDA regulated (pharmaceutical, biotechnology, or medical device) manufacturing setting

 

Preferred Qualifications:

  • Master’s degree or MBA
  • Knowledge in ISO & FDA regulations (such as ISO 9001, ISO 13485 or 21 CFR 820, 210 & 211).
  • Ability conduct quality investigations including root cause analysis and determining corrective/preventative actions.
  • Demonstrated ability to create and update standard operating procedures ("SOP").
  • Demonstrated validation experience in a regulated manufacturing industry.
  • Strong communication skills with the ability to collaborate at all levels and functions of the organization and with customers.
  • Ability to operate in a complex, matrixed, and fast-paced environment and gain consensus with groups; Pragmatic risk-based decision maker with strong problem-solving ability.
  • Collaborative and motivated team player. Always looking to share and advance best practices.
  • Experience with relevant data analysis software tools (Minitab) and methods
  • Working knowledge of Electronic Quality Systems (CAPA, Change Control, Documentation Management)
  • ASQ CQE, Green Belt or Black Belt

RSRMS

 

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

 

Curious? Apply and find more information at https://jobs.vibrantm.com

 

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

 

Job Requisition ID:  219510
Location:  Jaffrey
Career Level:  B - Recent University Graduate(<1 year of experien
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Nearest Major Market: Bellows Falls
Nearest Secondary Market: Keene

Job Segment: Biotech, Medical, CAPA, Pharmaceutical, Quality, Science, Healthcare, Management

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