Supplier Quality Engineer II

Duration: 09 Months

• Initial Duration: until end of Sep 2024. Possible extension until December 2024 at Danbury location and potential for conversion to FTE based on business need, budget approval and worker performance.
• Work Site: Danbury onsite 100%
• Travel Requirement: 60% travel between Danbury and Newark and visitation to supplier sites, both domestic and international. Travel expenses will be reimbursed.
• Shift: Standard first shift hours - 8am-5pm
• Interview Process: First Round: Virtual interview with hiring manager; Second Round: Virtual interview with Senior Director; Third and Final Interview: Onsite interview and tour with operations leadership.
• Sites having quality raw material problems.
• Post Market Surveillance around raw materials situations.
• R&D sustaining on raw materials specification changes.
• Other Departments, such as Supply Chain, Manufacturing Engineering, Quality Assurance, and Design Engineering, among others.
• Externally interacts with:
  Current and potential new suppliers of raw materials around the world.

Summary of Duties and Responsibilities:

• The following list is focused only on Electronics and Metal raw materials:
• Execute all applicable activities to comply with regulatory standards and meet the requirements established in the Quality Management System around supplier’s quality management.
• Conduct thorough technical reviews on raw materials suppliers to understand their capability to make parts.
• Oversee, assess, and monitor suppliers making parts as it relates to manufacturing, process and quality control practices, corrective action, continuous improvement, and “First Article Inspection”.
  Define and approve PPAP requirements for all new and revised purchased parts (as applicable). Follow up for their on-time completion.
• Work along with the raw material suppliers, to exceed the “fit, form and function” and reliability requirements, while working internally with Research & Development and Design Assurance.
  Issue and follow up on Agile Quality figures called “SCARs”, “SACAs”, and “NCEs” related to suppliers providing components.
• Monitor the timing of the workflows to comply with key performance indicators established by company.
• Work collaboratively with raw material suppliers on problem-solving and root cause analysis to avoid repeat failures.
• Apply (as applicable), metrology and statistical measurement to problem analysis and resolution.
• Work with Post Market Surveillance and other applicable departments (Quality Engineering, MFG Engineering, Research, and Development, etc.) to address complaints linked to raw material situations.
• Resolve quality day-to-day issues associated with raw material suppliers around the globe by addressing non-conformities: call into containment and work along with the corresponding departments to achieve disposition of the impacted raw material (return to supplier, rework, sort, etc.). If applicable, collect and send back samples to suppliers if needed.
• Work with Incoming Quality to include suppliers in the “Skip Lot Program”, or remove suppliers from it, if applicable.
• Maintain complete supplier quality records as per the applicable procedure (e.g., supplier performance key indicators, supplier quality certifications, etc.). Update raw material suppliers’ files when required and check that the information is accurate and complete, assuring that all applicable regulatory standards are met.
• Support audits as a subject matter expert. Travel might be required.
• Update the ERP system with the status of the approved suppliers for the different raw material components.
• As applicable, attend functional and departmental meetings and follow up on action items accordingly.
• If needed, coordinate the change in specifications and/or procedures when required through the corresponding change order.
• Train yourself in the respective procedures in the training system, before executing the respective task.
• Generate supplier performance metrics to be used in decision-making. Provide the necessary reports to the stakeholders.
• Coordinate Periodic Quality Review meetings with raw material suppliers that require it, as well as follow up on the activities agreed upon in these meetings to ensure that they are carried out.
• Coordinate and execute activities related to the implementation of new raw material suppliers as a result of the introduction of new products, transfer of products, alternate suppliers, etc.; ensuring that the component’s suppliers comply with the requirements stipulated in the quality system before the closure of the projects.
• Qualification of new suppliers and/or new parts/components of an already approved supplier.
  Perform other duties as required by his/her supervisor/manager.

Qualifications:

• Conflict management
• Planning
• Organized
• Handling ambiguity
• Decision quality
• Trust and integrity

Education:

• BS or BA degree preferred in Electronics, Electromechanical, Mechanical, or Metallurgy Engineering or similar engineering professions such as: Industrial Engineering, Biotechnology Engineering, and Chemical Engineering.

Experience:

• 0-2 years of experience as a graduated professional in the medical device industry or similar.
• For the Technical Certification/University Diploma, a minimum of 5 years of experience in positions of similar nature is required.

Specialized Knowledge (Desirable):

• ISO 13485 leader auditor (Desirable).
• Working knowledge of Medical Device Regulations, In Vitro Diagnostic Regulation, cGMP, CFR 820, ISO-13485, ISO-14971, and ISO-9001 (Desirable).
• Negotiation course (Desirable).
• Risk management (Desirable).
• Validations and root cause analysis (Desirable).

PPAP (Desirable).