Senior Supplier Quality Engineer

Novocure

Posted on: August 5, 2022

Closing: September 04, 2022

Salary: Undisclosed

Position Type: Full Time

Job Description

The Senior Supplier Quality Engineer in support of Novocure Supplier Quality and Supply Chain provides technical guidance and support to Novocure contract manufacturers and their suppliers in the areas of Medical Device Quality Assurance, Process Validation, Equipment Qualification and Quality Control.  This role ensures compliance to applicable regulatory requirements and procedures, while delivering to the objectives of applicable programs and strategic objectives, in alignment with both the Quality department and Supply Chain. This includes CAPA (SCAR) investigations, development and maintenance of SOPs supporting the collection and analysis of quality metrics, and supporting company expansion plans. The position contributes to a culture of Quality, teamwork and continuous improvement within the Operations business unit. In collaboration with business process owners, further develops product realization processes, ensuring stakeholder engagement and an effective process framework facilitating rapid and cost effective delivery of safe and effective products.

 

This is a full-time, exempt, remote role associated with our Portsmouth, NH office, reporting to Novocure’s Associate Director, Global Supplier Quality

 

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Works with other members of the QA organization and Supply Chain to deliver against strategic goals and improvement plans
  • Expands and improves the implementation of LEAN and Six Sigma methodologies both within Novocure and at its contract manufacturers and sub-tier suppliers.
  • Manage projects and issues cross-functionally for continuous improvement
  • Provides leadership when appropriate to manage team members or projects
  • Could teach and train on Supplier Auditing, Supplier Management, Projects, etc.
  • Reviews and provide input into supplier management procedures and processes and executes results
  • Acts and represents Supplier Quality as part of the Supplier Approval process
  • Acts as QA approver for contract manufacturer and sub-tier supplier test plans, process changes, tooling changes, process validations and equipment qualifications.
  • Ensure that for any deviation reported by Novocure (audit, complaint, NCMRs, others), a SCAR is efficiently implemented by the Supplier. If needed, support the supplier in the definition of the SCAR.
  • For critical suppliers, conduct Monthly Quality Meetings to monitor Quality KPIs and attends Quarterly Business Meetings
  • Collaborates with contract manufacturers/sub-tier suppliers in the review of process changes and improvements, investigations and root cause analysis of process deviations, corrections, corrective actions, out of trends, and OOS as applicable.
  • Optimize Improve the process
  • Leads and conducts Supplier Audits

QUALIFICATIONS/KNOWLEDGE:

  • Minimum of a Bachelor degree, preferably in a Science or Engineering discipline, with applied Quality Engineering experience of 8-10 years
  • ISO 13485 Certified Lead Auditor or CQA and 6 Sigma and/or LEAN experience preferred Certification or demonstrated experience applying LEAN and six sigma principles and methodologies.
  • Supplier and QMS auditing experience in medical device, pharmaceutical or comparably regulated field
  • Demonstrated experience writing, evaluated and executing process validations.
  • Demonstrate leadership and training skills
  • Ability to navigate through ambiguity and rapid growth and adapt to change.
  • Ability to self-direct, and adapt to changing priorities
  • Outstanding communication skills (verbal and written in English).
  • Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment; comfortable working within international, multicultural teams.
  • Curious mindset, allowing continuous learning and comfort challenging the status quo.
  • At least 8 years previous experience in similar position
  • Working knowledge of relevant FDA, EU regulations and ICH standards/guidelines.
  • Practical experience with Quality Risk Management, product lifecycle management (PLM) and process validation.

OTHER:

  • Standing and sitting for extended periods
  • Ability to lift up to 30 pounds

Novocure is taking a responsible approach to creating environments that allow us to strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.

 

As part of our commitment to health and safety, COVID-19 vaccines are required for our current U.S. employees.  As an Equal Opportunity Employer it is our policy to provide reasonable accommodations to any qualified individual, who, because of a medical condition, or sincerely held religious belief/practice, receives an exemption from the vaccination requirement, if such accommodation would not result in an undue hardship for the company.

 

For more information regarding the Novocure’s COVID-19 vaccination requirement, exemptions, and verification of vaccination status please ask the Talent Acquisition Team.

 

 

ABOUT NOVOCURE:

Our vision

Patient-forward: aspiring to make a difference in cancer.

Our patient-forward mission

Together with our patients, we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.

Our patient-forward values

– innovation

– focus

– drive

– courage

– trust

– empathy

Novocure

Posted on: August 5, 2022

Closing: September 04, 2022

Salary($): Undisclosed

Position Type: Full Time

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