Senior Supplier Quality Auditor (Remote) in Virtual, Arizona at Stryker Corporation

Date Posted: 10/22/2018

Job Snapshot

Job Description

Who we want-

* Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

* Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions

* Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations

* Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions

What you will do-
Lead supplier evaluations in the Global Supplier Quality 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 observations, NCs, CAPAs and communication of evaluation results to key stakeholders.  Provide cross-functional supplier auditing services to Stryker’s R&D, Acquisition, Manufacturing, Materials, Purchasing, and Operations stakeholders worldwide.     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 related to compliance:

  • Complete risk-based audits of suppliers per Stryker’s required cycle times to ensure conformance and compliance
  • 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 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
  • Train and educate suppliers on GMP, regulatory requirements, and Stryker expectations

Responsibilities related to sustainment:

  • 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 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
  • Drive improvement by identifying and communicating ineffective or inefficient Quality Management System processes
  • 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

What you need-

Required:

  • 3-5 years of relevant experience in Quality, Management, or Engineering
  • Bachelor of Science in engineering, or engineering related discipline
  • Demonstrated collaboration, negotiation, and conflict resolution skills
  • Demonstrated ability to lead, champion change, and execute strategies to meet goals
  • 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
  • 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
  • Knowledge of Quality Management Systems, FDA 21 CFR Part 820, ISO13485 and/or ISO9001
  • ASQ or RABQSA certification preferred (i.e. CQE, CQA, Lead Auditor)
  • Work from home ability. *Remote position*
  • Travel is approximately 60%
  • Must be able to travel internationally
  • Regular travel to supplier facilities

Preferred:

  • ISO-13485 Lead Auditor certification or equivalent
  • Experience in medical device industry
  • Experience working onsite developing suppliers
  • Experience conducting supplier audits and internal audits

Work From Home: Yes

Travel Percentage: Up to 75%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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