DNA Genotek

Supplier Quality Specialist (BB-5C97B)

Found in: Neuvoo Bulk CA

Description:

Overview:

The focus of this position is to establish, strengthen and support our Supplier Management Program.   For the purpose of this job description, “suppliers” can be suppliers, contract manufacturers, service providers, distributors or consultants.


Responsibilities:

  • Establish, maintain and continuously improve the Supplier Management Program
  • Receive and process requests to qualify new suppliers
  • Establish and maintain the DNA Genotek Supplier Audit Schedule
  • Perform supplier desk top evaluations and on-site supplier audits
  • Establish and maintain DNA Genotek’s Approved Supplier List and Approved Distributor List
  • Document and track supplier nonconformities via the Supplier Corrective Action process
  • Support resolution of supplier quality issues and drive supplier quality improvement
  • Evaluation of supplier responses to quality issues
  • Establish and maintain the Supplier Performance Monitoring process
  • Establish and maintain the supplier notification of change process, including processing supplier notifications of change
  • Establish and monitor supplier improvement plans
  • Readily identify supplier risks
  • Communicate supplier quality issues at DNA Genotek Material Review Board Meetings
  • Communicate supplier quality issues at DNA Genotek Quality Board Meetings
  • Prepare supplier quality metrics for DNA Genotek Management Review Meetings
  • Support complaint investigations related to suppliers
  • Support other QA activities as directed by the Quality Assurance Manager and/or Sr. Director of Quality Assurance, as needed
  • As a key member of the Quality team, contribute to continuous improvement of all aspects of the quality system.
  • Expected travel requirements <30%.


Qualifications:

 EDUCATION:

  • Degree in a science or engineering discipline, or an equivalent combination of relevant job experience, training and knowledge.
  • Recognized Quality Management System training or certifications such as Certified Quality Engineer, Certified Supplier Quality Engineer.
  • ISO 9001 / 13485 auditor certification an asset.


EXPERIENCE and QUALIFICATIONS:

  • Minimum 5 years’ experience in a role that included resolving challenging technical problems with suppliers, preferably in the medical device or similarly regulated industry.
  • Experience in a supplier quality position, e.g. Supplier Quality Engineer, Supplier Quality Auditor, Supplier Quality Associate, or Supplier Quality Manager.
  • Experience building productive, collaborative relationships with suppliers.
  • Excellent understanding of quality systems, supplier quality and supply chain management.
  • Familiar with probability, statistical methods and sampling plans.
  • Demonstrated strong analytical ability and technical judgment.
  • Demonstrated strong planning, organization and time management skills.
  • The ability to prioritize tasks in a busy work environment.
  • Excellent written and oral communication skills in English.
  • Strong familiarity with ISO 9001:2015, ISO 13485: 2016 and Medical Device GMP regulations.
  • Strong familiarity with Supplier Corrective Action processes.
  • Proficiency in MS Office Applications.
  • Able and willing to occasionally travel to supplier or customer sites, including internationally.


CORE requirements

  • Team-oriented
  • Organized
  • Dependable
  • Enthusiastic
  • Motivated
  • Integrity
  • Analytical


At DNA Genotek, we are committed to building and preserving an accessible, welcoming, supportive, fair, and inclusive environment.

Accommodations are available to support prospective employees during the recruitment and hiring process. Should you require any accommodations, please advise us in advance so that we can work with you to find a suitable accommodation.

 

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