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Supplier Quality Engineer - Irvine, CA #4675288

Company: Vyaire Medical

Date: 03/14/2018

Category: Biotechnology / Pharmaceuticals

City: Irvine, CA

Supplier Quality Engineer

    • Supplier Quality Engineer


Job Category:Quality & Regulatory Affairs

Position DescriptionSupplier Quality Engineer

Vyaire Medical is seeking an experienced Supplier Quality Engineer for its growing enterprise. The Supplier Quality Engineer is responsible for developing and managing collaborative supplier relationships to ensure on time delivery of supplied products that meets the engineering and program requirements throughout Vyaire global Operations for consumable and capital equipment. Supplier QualityJD Engineering is responsible for managing suppliers including documentation, product and process qualification, and non-conforming product.

This position would report to Director of Global Supplier Development with a dotted line to the Director of Global Quality.

In particular you can expect to:

  • Participate on teams, being the primary quality point of contact, working with suppliers both domestically and internationally. Traveling is approximately 25%

  • Conducts on site audits (21 CFR Part 20, ISO 13485 and ISO 9001) and supplier performance evaluation required based on company procedures. Will ensure compliance with the supplier performance management system. Manage CAPA for QMS non-conformances identified. Measures suppliers’ performance through data analysis and trending. Conducts trend analysis, identify system issues, summarize findings and prepare reports for key quality and product metrics.

  • Responsible for reporting of quality trends and information to management on the performance of sourcing-related quality systems.

  • Responsibilities also include being the supplier QE representative in technical teams, initiating SCARs for non-conformances, setting priorities for corrective action efforts, and working with the team on component related failure investigations.

  • Responsible for supporting Development/Operations Engineering and manufacturing to resolve technical issues and implement corrective and preventive action.

  • Drive continuous improvement efforts, through facilitating, and collaborating with cross function teams including Vyaire and Suppliers.

  • Coordinate and document internal and external process validations.

  • Develop positive relationships and work closely with Global Sourcing Leaders and Procurement/Supply Chain to manage and implement supplier/engineering changes, New Product Introductions, and transfers.

  • Develops collaborative working relationships with suppliers to properly identify and mitigate potential production and/or manufacturing constraints for an on-time delivery of purchased products.

  • Interfaces with the suppliers' engineering, manufacturing and procurement departments as well as the respective internal Vyaire departments to drive cost effective manufacturing process improvements that optimize throughput and minimize waste.

  • Work with supplier to establish a structured approach for consistency and adherence to quality procedures and requirements.

  • Follow up non-conforming from the supplier audit, during-process inspection, pre-shipment inspection, quality complaints from internal customers, product returns and safety recalls. Identify / drive root cause analysis, corrective action and preventive action implementation.

  • 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

  • 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:

  • Bachelor's degree in technical field and 4-5 years’ experience is required; or equivalent combination of education and experience.

  • Working knowledge of manufacturing processes and the ability to support supplier development activities, continuous improvement initiatives and quality management tools.

  • Competent in Auditing, CAPA, Equipment Qualification.

  • Experience in medical device electro-mechanical system components (motors, PCBAs, cables, etc.) a plus

  • Six-sigma certification a plus.

  • Knowledge of statistical methods and Statistical Process Control (SPC).

  • Candidate must have high energy and lots of stamina. Must be a team player, and have a strong work ethic.

  • Must have good communication skills.

Some logistics:

  • Location: Irvine, CA

  • Travel: 25%

  • 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

One of our unique strengths is the diversity of our community. We want to treat each teammate fairly and provide equal employment opportunities regardless of a person's race, color, religion, gender or gender identity, sexual orientation, age, marital status, national origin, veteran or disability status, or any other characteristic.

This job is expired and moved to the archive.

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