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Supplier Quality Engineer (CDMO)

 

A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 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.    

 

 

US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by The Company. The Company uses the definition of "fully vaccinated" assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.

 

More Info - https://www.emdgroup.com/careers/us/Disclosure-Notice-COVID-Vaccination-Policy-State-Restrictions.pdf

Your Role:

  • Responsible for supplier quality management program for Life Science (LS) sites, specifically focusing on the LS CDMO (Contract Development and Manufacturing Organization) sites
    • Implementation of supplier quality management program
    • Project plan development
    • Training
    • Skills and competency assessments
    • Site audits, recurring follow up meetings
  • Responsible for assisting LS sites globally with implementation of Quality agreements with critical suppliers
  • Responsible for supporting LS Supplier Risk Management Program
    • Support Supply Chain on current critical supplier risk management program
  • Responsible for supporting process excellence team with critical suppliers
    • Lean manufacturing training
    • Statistical process control training

   General Position Responsibilities:

  • Responsible for working with all LS CDMO sites globally to drive and implement Supplier Quality Management
    • Provide training and guidance
    • Drive completion of site level project plans to support initiative deliverables
    • Assess site supplier quality engineer skills and competencies and provide or facilitate required training and mentoring as gaps are identified
    • Lead and or participate in site team meetings.
    • Drive the implementation of supplier quality agreements
    • Oversight of third-party suppliers, schedule and participate in third party supplier audits.
  • Assist and participate on integration teams as needed
  • Define, train, coach, mentor, and implement Supplier Quality Management program at existing and/or recently acquired sites as required.
    • Provide guidance and training on Supplier management, supplier auditing techniques, supplier corrective actions, contractual flow down of requirements, purchase specifications, etc.,
  • Schedule and lead Supplier Quality site audits to ensure compliance to LS global management procedure.
  • Develop and or change relevant site and or LS procedures as needed.
  • Schedule and perform supplier audits for other MilliporeSigma sites as needed.
  • Lead in Supplier Quality improvement teams, manage supplier yield/data reporting and ensure continuous improvement. 
  • Work with sites/suppliers to improve quality, reduce costs, and maintain on-time deliveries.
  • Provide Technical assistance as needed, to address customer complaints, chronic supplier issues, etc. to prevent recurrence.
  • Active team member on related supply chain teams.
  • Ensures MilliporeSigma’s Purpose, Vision, and Values are practiced in the performance of the position responsibilities to meet or exceed our Customers’ expectations.

 

Open to locations Indianapolis, St. Louis or Burlington. Open to remote as well for best fit.

 

 

Who You Are:

Position requires complete understanding and application of principles, concepts, practices, and standards.  This candidate will develop imaginative and practicable solutions to a variety of complex problems which will support organization’s objectives. Must be a self starter who can multi-task and is able to work under minimal direction.  Candidate will participate in determining objectives of assignments.  Plans schedules and arranges own activities in accomplishing objectives.  Work is reviewed upon completion for adequacy in meeting objectives. 

 

Minimum Qualifications:

  • 4-year degree in engineering or technical discipline (Chemistry, Biology, Microbiology, Pharmacy), or equivalent in combination of experience and education
  • Experience working with CDMO’s (Contract Development and Manufacturing Organization)
  • Excellent technical writing and verbal communication skills.
  • Detail oriented with strong analytical and problem-solving skills.
  • Ability to work independently and remotely.
  • Strong organizational skills.  Must be able to simultaneously manage multiple projects across multiple capabilities and functions with competing priorities and requirements in support of global time zones
  • Strong computer skills including experience with Microsoft Office applications and database software.
  • 1-3 years project management experience
  • 7 years (minimum) Supplier Quality Management or Quality Systems experience
  • Formal training in the following:
    • Lead auditor training
    • Root Cause and Corrective Action
    • Preventive Action
    • Statistical Process Control
    • Six Sigma tools
    • Risk Management

 

Preferred Qualifications:

  • Experience developing and implementing a Quality Management System a plus.
  • Knowledge of regulatory standards including cGMP, ISO 13485 and/or ISO 9001. Knowledge of FDA QSRs a plus.
  • ASQ Certified Quality Auditor or Certified Supplier Quality Professional preferred
  • ASQ Certified Quality Engineer, Certified Six Sigma Green Belt, Certified Manager of Quality/Organizational Excellence, Certified Six Sigma Black Belt a plus
  • Experience with multi-national corporations a plus
  • Experience in applying Lean manufacturing and/or Six Sigma tools in a manufacturing environment will be a strong plus.
  • Demonstrates advanced knowledge of Quality Assurance Systems, Risk Management, Engineering, including technical documentation, with a basic understanding of business knowledge.
  • Demonstrates advanced knowledge and ability to interpret regulatory requirements including FDA, EMA, MHRA, and Rest of World cGMP regulations for pharmaceuticals
  • Demonstrates the ability to effectively manage and prioritize multiple projects and tasks.
  • Demonstrates  excellent written and oral interpersonal skills.
  • Demonstrates coaching and mentoring skills
  • Demonstrates ability to influence others and negotiate contracts
  • Some travel required (5-10%)

 

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!

Our Benefits - https://www.emdgroup.com/en/careers/benefits.html

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

If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

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:  242479
Location:  Burlington
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

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 Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request.  You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

Notice on Fraudulent Job Offers
Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information.


Nearest Major Market: Boston

Job Segment: Quality Manager, Microbiology, Public Health, QA, Quality, Science, Healthcare

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