Quality Engineer 4- Supplier Quality Management

Job Description

Organization: Siemens Healthineers
Business Unit: Strategic Procurement
Requisition Number: 237400
Primary Location: United States-California-Mountain View
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 25%

Division Description:

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Job Description:

The Supplier Quality Management organization within Siemens Healthineers, Ultrasound Business unit is seeking a dynamic and high-potential individual to join the team as a Supplier Quality Engineer 4.  The Supplier Quality Engineer (SQE) is an engineering and supplier facing position responsible for driving operational excellence with suppliers / OEMs in alignment with corporate objectives.

 

The SQE will be involved throughout the product lifecycle.  This includes providing quality expertise and oversight for the selection and qualification of the supplier and the support for launch of product into the supplier which includes supplier readiness and product qualification activities following APQP/PPAP practices. 

 

The SQE will also be responsible for building strategic partnerships with suppliers and OEMs to ensure that supplier quality processes are meeting business goals and quality standards.  Through supplier monitoring and continuous improvement activities and by leading quality initiatives with suppliers the SQE will drive improved purchased part/service quality, drive quality system improvements, reduce Non-Conformance Costs and ensure compliance to regulatory and procedural requirements.   The candidate will be a qualified lead auditor and will be responsible for performing audits on suppliers as part of supplier qualification and to assure products and services meet ISO13485 / ISO9001 and relevant regulatory standards.  

 

The Supplier Quality Engineer 4 will report in to the Director of Supplier Quality Management.  The candidate must be able to work independently, interface effectively and demonstrate a high level of reliability, integrity and personal accountability as a member of the Supplier Quality Management team. 

 

Responsibilities

·         Collaborate with Procurement and Engineering in the supplier selection process and  support Early Supplier Involvement with input into design to achieve manufacturability and target cost

  • Lead supplier qualification processes for responsible suppliers including:
    • Evaluate and qualify suppliers based on selection criteria.
    • Plan and execute Supplier Audits (scheduling, conducting, reporting and follow-up of SCAR measures)
    • Lead development of Quality Assurance Agreements with Suppliers.
    • Support release of Supplier to Qualified Status in accordance with established procedures and processes.

  • Support preparation and execution of part qualification plans with engineering and NPI teams including:

o    Interface with PLM & SCM Engineering teams, Procurement and Operations to ensure products/ components are in accordance with specifications

o    Working with engineering and suppliers to establish qualification criteria for new products

    • Support supplier new part qualification activities, including capability studies and control plans that define the supplier’s processes and identify areas of risk.
    • Understand and represent supplier capabilities to engineering teams during program design changes / development.

o    Manage quality readiness for commercial ramp up of Product manufacturing at the Supplier / OEM.

o    Review and approve supplier quality plans on new part programs

o    Discuss part critical characteristics and required process controls

    • Have working knowledge of APQP / PPAP processes and support implementation of best practices into existing procedures and processes.

·         Drive Supplier Development activities including:

    • Prepare supplier development plans to define, lead and track supplier quality & manufacturing improvement programs

o    Maintain and analyze key performance indicators and cost of poor quality data to identify recurring trends and drive improvement actions to reduce internal and external failures and related costs

o    Review, drive corrective actions, and approve supplier issues (Non-conforming material, corrective action requests etc).

o    Assist in investigations to determine root cause(s) of product defects including field and internal failures

o    Actively participate in supplier performance reviews

  • Assist Quality Director in establishing, implementing and maintaining the Strategic Procurement procedures and processes.  Provide input to drive lean processes and drive departmental continuous improvement projects to improve procedure and processes efficiency to better support the business.

·         Apply quality system knowledge and exercise audit readiness skills and techniques within the organization and participate in external regulatory audits as a member of the Supplier Quality Management team.

 

Required Knowledge/Skills, Education, and Experience

  • Minimum of Bachelor’s Degree in Engineering or equivalent program or equivalent combination of education and experience. 
  • 8 years’ experience in Supplier Quality Management or other Quality related functions with a minimum of 3 years’ experience in the medical device industry.

·         Lead auditor training (ISO 13485, or ISO 9001) and 3+ years’ experience conducting supplier audits

·         First-hand knowledge of applicable US (21 CFR 820) and EU (ISO 13485) quality system requirements, with a focus on quality management, supplier controls, nonconformance, corrective and preventive action

·         Experience preparing for and participating in third party / regulatory QMS audits

·         Experience working with new product introduction into manufacturing environment or at Suppliers.

  • Highly developed writing, communication, and interpersonal skills with the ability to work on diverse teams located at different geographical locations.
  • Effective analytical and problem solving Skills
  • Ability to work with the assigned supply base to reach long-term corrective action on quality issues and assist in the development of new supplier processes. 
  • Good data mining and computer skills (Word, Excel, PowerPoint, Minitab, Visio, Microsoft Project/scheduling, Metric/chart creation).
  • Experience authoring and/or improvement of related QMS procedures/processes meeting regulatory and other requirements. 

 

Preferred Knowledge/Skills, Education and Experience

·         Certified Lead Auditor with at least 5 years’ experience planning and leading supplier QMS audits.

  • Lean/6-Sigma Methods and Principles

·         Prior experience managing a supplier audit program (planning, scheduling, conducting and reporting)

·         Prior experience with managing a CAPA and/or SCAR program

  • SAP experience a plus

·         Knowledge of AIAG standards including APQP and PPAP requirements including FMEA, Control Plans, Flow Charts, R@R, SPC, MSA, Capacity Analysis, GR&R

 

*LI-WC1

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