Sr. Principal Engineer, Supplier Quality

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Location: Irvine, CA US
Job Category: Quality & Regulatory Affairs
Position Description
Sr. Principal Engineer, Supplier Quality

Vyaire Medical is seeking an experienced Sr Principal Engineer, Supplier Quality (SQE) for its growing enterprise.  The SQE team lead responsible for leading the Supplier Quality/Development platform within the Respiratory Consumables business (i.e. new supplier qualification/assessment and monitoring/measuring the existing supplier base), support design transfer, product and equipment qualification (IQ, OQ, and PQ), as applicable, and driving supplier development opportunities.  The incumbent will maintain close communication with the Global Sourcing Quality Manager, in resolving major supplier quality initiatives/projects.

The SQE will be the Yorba Linda’s site purchasing control subject manner expert and will be a conduit between the supplier and Vyaire functions.  The SQE must be able to work cross functionally with Shared Services (e.g. Regulatory Affairs, Customer Advocacy, Sterilization Assurance, Packaging Technology Center, etc.) as well as Design Assurance, R&D and Product Engineering, Marketing, Operations, Planning/Buying, and Strategic Sourcing to effectively maintain and manage Vyaire’s supplier management system.  This position will report to Global Sourcing Quality Manager.

In particular you can expect to:  

  • Lead new supplier qualification/assessment of finished goods, components, raw materials, and/or services
  • Monitor/manage existing contract manufacturers, private label & joint label suppliers to verify adherence to product requirements and ensure compliance with applicable FDA and International regulations
  • Responsible for reporting quality trends and information to management regarding the performance of sourcing product/process issues, including escalation of any significant issues
  • Accountable and responsible for administering of the Supplier Quality/Development program (i.e. Supplier Selection, Qualification, Maintenance, Development, etc) for Respiratory Consumables sourced products and services
  • Ensure the corrective and preventive actions to problems/issues relating to process and/or product quality, such as complaint resolution, customer interface, and regulatory action are properly executed
  • Interact with external compliance authorities and internal assessment groups to demonstrate regulatory compliance and product safety and efficacy
  • Serve as commercial manufacturing/supplier quality representative during new product launches/transfers and modifications of sourced product into production including process validation (IQ, OQ, PQ) activities, change control board representation/approval and acceptance of product/process from design assurance and engineering
  • Recruit, retain, train, develop, manage, and lead quality personnel.  Provide direction and leadership to direct reports in order to maintain and improve quality operations
  • Support continued compliance with all regulatory standards/requirements and worldwide regulatory authorities, including but not limited to CFRs, MDD, ISO, FDA, BSI, TUV and others as we continue to expand product distribution and service
  • Assist the BU and Plant Management Representatives in preparation for third party audits (i.e. FDA inspections & notified body audits) and in the effective closure of findings resulting from such audits
  • Alternate Supplier Quality Management member on the PCN, SET, and CCB
  • CAPA/SCAR Champion - drives CAPA throughout organization and supplier development
  • Perform other work-related duties as assigned

You will have the opportunity to:

  • Improve patient outcomes
  • Meaningfully impact the company’s short-term and long-term success
  • Work closely with executives across the organization
  • Grow your role as you see fit
  • Learn everything there is to know about respiratory medical device manufacturing
  • Create an inspiring workplace

To be successful, you will need:

  • 7+ years’ relevant professional medical device experience in the following areas: Quality/Supplier Quality Engineering, leading quality system audits, medical device manufacturing, design transfer, process validation (IQ, OQ, PQ), statistics and sampling methods, CAPA root cause analysis, and purchasing controls.
  • A Bachelor’s degree (or equivalent) in a technical or engineering is required from an accredited four (4) year university
  • A Master’s degree in a technical field or engineering degree is strongly preferred
  • Strong familiarity with regulatory requirements (FDA QSRs, ISO 13485, MDD, CMDR, J-PAL), risk management (ISO 14971), statistical software (MiniTab), and Six Sigma Methodology
  • Excellent verbal and written communication skills
  • Team-oriented with strong interpersonal and situational management skills
  • Ability to work independently and effectively in a fast-paced environment
  • Leadership skills, results and solutions oriented mindset
  • Effectively able to manage tight deadlines with multi-suppliers and -tasks simultaneously
  • Project Management skills
  • ASQ certification in Certified Quality Manager (CQM), Certified Quality Engineer (CQE), Six Sigma Black Belt (SSBB), and/or Certified Quality Auditor (CQA) is strongly preferred
  • Molding experience is strongly preferred
  • Chinese (Mandarin/Cantonese) speaking strongly preferred

Some logistics:

  • Location:  The current office is based in Yorba Linda however we be moving to the Irvine area. Once property is identified in Irvine this position will relocate to the new space based in the Irvine area.
  • Travel: Up to 50%.
  • Physical Demands: May require light physical effort as in periods of prolonged standing, sitting at files or work tables or bending, stooping or reaching and/or occasional lifting of light items (i.e. up to 30 lbs). May require some exposure to chemicals used in manufacturing processes.

 

Irvine, CA

 

Full time
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