Stryker Staff Supplier Quality Engineer - Remote in New York
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
Who we want:
Business-oriented evaluators . People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams.
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.
Stryker is hiring a Staff Supplier Quality Engineer – Remote to be located in the United States. This role will be virtually based, preferably within a reasonable driving distance of a Stryker location.
This is an M&A (Mergers and Acquisitions) focused role where you will perform supplier assessments, conduct supplier quality improvement projects, escape prevention, and manage various supplier quality activities throughout the pre-close confirmatory diligence and post-close integration execution phases.
What you will do:
As a Staff Supplier Quality Engineer, you will serve as a liaison between suppliers and Stryker to drive effective continuous improvement to the supplier base; work with internal customers and suppliers to support supplier quality issues, provide technical support for activities related to supplier quality system assessment and performance evaluation; collaborate with the strategic sourcing, auditing and development groups to understand the capabilities and competencies of suppliers to fulfill product quality and regulatory requirements.
Own Supplier related CAPA review and management, ensuring effective use of appropriate problem-solving tools.
Support tracking and reporting of KPI and other metrics associated with supplier performance.
Provide education and training to suppliers as necessary.
Articulate detailed supplier performance results and trends to appropriate levels of management.
May support supplier PPAP and supplier-initiated change activities.
Perform detailed process reviews at supplier's manufacturing site.
Assess and critique supplier process control documentation, identifying areas of improvement and driving improvement within the suppliers QMS.
Communicate effectively to suppliers and internal stakeholders.
Maintain and track to completion closure of assigned supplier action items.
Collaborate with external/internal teams and stakeholders to prioritize supplier-initiated change requests.
Develop and drive completion of personal development plans (IDP).
Support PMO projects and initiatives.
Develop relationships with suppliers and internal cross functional partners.
Identify and execute on cost reduction opportunities through quality improvements at suppliers.
Manage and execute supplier-initiated changes for continuous improvement, cost reduction or supplier remediation activities.
Analyze non-conformance data to prioritize projects and to solve systemic supplier issues.
Execute pro-active supplier site visits and supplier audits.
Transfer “lessons learned” from the supply base back to R&D and other functions for incorporation into next generation designs.
Provide problem solving expertise at supplier locations in support of critical quality issues.
Key Areas of Responsibility
Train, mentor and assist in the development of less experienced engineers.
Propose and develop effective quality improvement plans to be implemented at appropriate suppliers.
Provide support to 3rd Party Audits relating to Supplier Quality CAPA.
May act as a single point of contact for Strategic Business Partners and in some cases for Strategic Suppliers.
Serve as a subject matter expert, for assigned commodity, share expertise within global Stryker organization.
Lead or Oversee project portfolio of supplier improvement activities.
Collaborate with external/strategic partners to identify companywide opportunities for supplier improvement.
Drive standardization of SQ-related processes.
What you will need:
Bachelor’s Degree in a Science, Engineering, or related discipline
4+ years’ experience in quality, engineering, and/or manufacturing
Lead Quality Auditor Qualification preferred (ISO 13485, CFR 820 or comparable industry standard and regulatory requirements).
ASQ CQE/CMQ/OE/PE certification preferred.
Lean Six Sigma green certification preferred.
Experience in a highly regulatory environment desirable.
Working knowledge of FMEA, validation programs and SPC processes.
Strong understanding of manufacturing prints and tolerancing.
Working knowledge in statistics.
Strong interpersonal skills, written, oral communication and negotiations skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.
Working knowledge and understanding of manufacturing processes.
Thorough knowledge and understanding of US and International Medical Device Regulations.
Good understanding of project management.
Demonstrated working knowledge to positively influence supplier quality performance.
Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.
Demonstrated ability to work in cross-functional team environments.
Ability to plan, organize, and implement multiple concurrent tasks.
Good knowledge of continuous improvement methodologies.
Good knowledge of lean tools and concepts. Demonstrated the ability to apply lean
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