AT02 - Auditor - Operations

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 Supplier Quality Auditor 

 

Location: Redmond, WA 

Pay: up to 53 an hour 

Contract: 11 months 

 

Basic Function

Lead supplier evaluations in the Global Quality & Operations (GQ&O) audit program to support the evaluation, selection, approval, and monitoring of suppliers and manufacturing partners.  The role is responsible for the coordination and implementation of on-site and documentation audits, related CAPA and communication of evaluation results to key stakeholders.  Provide divisional and cross-functional supplier auditing services to Stryker’s R&D, Acquisition, Manufacturing, Materials, Purchasing, and Operations stakeholders worldwide.  Work with cross-divisional and cross-functional component suppliers, contract manufactures, and original equipment manufacturers to drive process improvements of the quality systems.  Sr. Audit Supplier Quality Engineers act as a technical liaison between suppliers, Engineering, Purchasing, and Manufacturing, to support projects and to resolve divisional and site quality issues.   Sr. Audit Supplier Quality Engineers partner with more experience staff.  They are viewed as divisional and cross-functional subject matter expert in Quality and auditing.  Ensure purchased components, sub-assemblies, and devices comply with all print specifications and applicable regulations.  Supply information into the metrics, trends, and performance indicators of suppliers in order to drive continuous improvement throughout the supply chain.  Provide input into the supplier performance information and selection of new suppliers for the Stryker Global Approved Supplier List.  The top three performance objectives for this role are: (1) drive continuous improvement within the Stryker supply base, (2) ensure compliance and conformance, and (3) ensure effective and efficient Quality Management Systems are established, documented, implemented, and maintained.

Responsibilities

Responsibilities related to compliance:

  • Complete risk-based audits of suppliers per Stryker’s required cycle times to ensure conformance and compliance
  • Lead timely and compliant Operations audits as required and directed by the internal audit program
  • Provide compliant records for FDA, ISO, Corporate, Internal, 2nd party, and Operations audits
  • Ensure supplier Quality Management Systems comply with applicable FDA and ISO regulations and requirements
  • Identify and write findings and observations during evaluations and drive timely closure of NCs through the CAPA system
  • Ensure components, sub-assemblies, and devices meet all print specifications and applicable regulations
  • Work with suppliers to quarantine all suspect and non-conforming material, as required
  • Issue supplier corrective action requests, as required, and drive suppliers to identify, correct, and prevent the root cause
  • Participate in supplier audits, supplier evaluation, and supplier monitoring as required
  • Train and educate suppliers on GMP, regulatory requirements, and Stryker expectations

 

Responsibilities related to sustainment:

  • Evaluate processes, write audit reports, write non-conformances, and store records per Document Control requirements
  • Ensure a timely supply of conforming components and products to Stryker through process sustainment
  • Root cause analysis of processes related manufacturing defects and warranty concerns
  • Communicate results of supplier evaluations to Stryker stakeholders and suppliers to ensure adequate responsiveness
  • Identify and communicate supplier initiated changes and ensure the suppliers follow change control requirements
  • Serve as a subject matter expert for supplier evaluations, share expertise within the division and site
  • Support manufacturing transfer projects through the effective and efficient evaluation of suppliers and processes

 

Responsibilities related to development:

  • Foster strong relationships with Stryker’s supplier-partners acting as an extended enterprise
  • Complete on-site audits of suppliers’ Quality Management Systems through risk based processes audits
  • Drive improvement by identifying and communicating ineffective or inefficient Quality Management System processes
  • Report non-conformance and performance data to highlight systemic supplier issues
  • Support the creation and execution of supplier development plans by identifying potential process improvements
  • Drive continuous improvement actions within supplier processes to reduce part related defects (DMP)
  • Evaluate and qualify new suppliers and advanced technology processes to support product innovation
  • Support strategic sourcing decisions by identifying supplier capabilities and providing input for supplier selection
  • Partner with suppliers on Quality topics:  Quality System, problem solving, validation, and lean
  • Communicate “lessons learned” from the supply base to R&D for incorporation into next generation designs
  • Become recognized and trusted as a divisional and site auditor expert and resource

Supervisory Responsibilities

 

Blood Borne Pathogen Category A Position

   

Physical Requirements

  • Sedentary work: Exerting up to 20 pounds of force occasionally and/or a minimal amount of force frequently or constantly to lift, carry, etc.
  • Must be able to operate common office equipment (e.g. calculator, fax machine, telephone, etc.).
  • Travel is approximately 50%
    • Regular travel to supplier facilities required
    • Must be able to travel internationally

Mental Requirements

  • Must be able to learn and explain detailed quality procedures
  • Must be able to plan, organize, and implement multiple concurrent tasks
  • Must be able to work independently; motivated to perform at a high-level without supervision
  • Must possess the ability to understand business processes and how the Quality role impacts the business processes

Qualifications/Work Experience Preferred

  • 3 years of relevant experience in Quality, Management, or Engineering
  • Experience in medical device industry preferred
  • Experience working onsite developing suppliers preferred
  • Experience conducting supplier audits and internal audits preferred
  • Demonstrated collaboration, negotiation, and conflict resolution skills
  • Demonstrated ability to lead, champion change, and execute strategies to meet goals
  • Critical thinking and strong analytical skills
  • Comprehends production/process controls, FDA verification/validation, problem solving, & root cause
  • Comprehends quality planning tools:  APQP, PPAP/FAI, FMEA, MSA, Control Plan, & Control Charts
  • Comprehends statistics and use of Minitab software:  SPC, MSA, DOE, and Process Capability
  • Strong communication skills, verbal and written
  • Excellent time management and organization skills, with high emphasis on attention to detail
  • Advanced working knowledge of Microsoft Word, Excel, Outlook, PowerPoint, Visio, and Adobe 

Education/Special Training Required

  • Bachelor of Science in engineering, or engineering related discipline required
  • Knowledge of Quality Management Systems, FDA 21 CFR Part 820, ISO13485 and/or ISO9001 required
  • ASQ or RABQSA certification preferred (i.e. CQE, CQA, Lead Auditor)
  • ISO-13485 Lead Auditor certification or equivalent preferred