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Supplier Quality Engineer

Your Role:

The Supplier Quality Engineer (SQE) is responsible for ensuring the quality of raw materials used in the production of membrane and pharmaceutical filter products. The SQE will drive major risk reduction initiatives with suppliers to foster supplier continuous quality improvement culture. The desired candidate must be capable of leading supplier audits in accordance with MilliporeSigma and ISO 9001 standards. The SQE must have knowledge of reading and interpreting complex engineering drawings, conducting gage reproducibility and repeatability (R&R) studies, root cause methodology, implementation and monitoring of corrective actions with suppliers, and understanding of validation principles and requirements in a cGMP and GAMP environment. 

 

Essential Job Functions:

  • Manage supplier non-conformances to ensure root cause is addressed with timely and effective corrective and preventative actions employing proper root cause analysis methods.
  • Conduct supplier audits using a risk-based auditing strategy to identify quality risks and gaps.
  • Collaborate with suppliers to drive risk mitigation and ensure effective process controls are in place and are sustained.
  • Provide support to incoming inspection and establish disposition plans for quarantined raw material.
  • Assist in the initiation and maintenance of Supplier Quality Agreements.
  • Provide sound quality and validation input to supplier qualifications (new suppliers, raw material changes, mold tool changes, etc). Ensure all changes follow internal Quality Management Systems. (change control, CAPA, etc).
  • Maintain standardized metrics that guide actions and promote continuous improvement (e.g. supplier performance, SCAR responsiveness, etc). 
  • Provide supplier quality guidance to business partners and lesser experienced engineers.
  • Travel to domestic and international supplier locations (20%).

 
Who You Are:
Minimum Qualifications:

  • 1+ years managing supplier audits and raw material dispositions.

 
Preferred Qualifications:

  • BS degree in a Quality, Technical or Engineering discipline  preferred
  • Experience conducting supplier audits is preferred.
  • Understanding or experience with ISO & FDA regulations (such as 21 CFR 820, 210 & 211).
  • Certifications:
    • Black Belt or Green Belt
    • CQA or CQE
    • ISO Auditor
  • Strong written and verbal communication skills.
  • Collaborative and motivated team contributor.
  • General knowledge  of supplier quality in a medical or pharmaceutical manufacturing environment.
Job Requisition ID:  209627
Location:  Jaffrey
Career Level:  D - Professional (4-9 years)
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.

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