Staff Engineer, SQ Compliance in Cork at Stryker Corporation

Date Posted: 9/22/2019

Job Snapshot

Job Description

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.

Key Areas of Responsibility

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. 
Performs  PPAP activities for supplier changes                                                                                                                           Perform detailed process reviews  at supplier's manufacturing site. 
Assess and critique supplier process control documentation, identifying areas of improvement and driving improvement withing 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 wtih suppliers and internal cross functional partners.
Identify and execute on cost reduction opportunities through quality improvements at suppliers.                     Participate in supplier audits, as required.
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.
Transfer “lessons learned” from the supply base back to R&D for incorporation into next generation designs.
Provide problem solving expertise at supplier locations in support of critical quality issues.  
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 activites.
Collaborate with external/strategic partners to identify company wide opportunites for supplier improvement.   
Oversee processes as a process owner and drive standardization of SQ-related processes such as PPAP, DPM, etc

Knowledge / Competencies

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 concepts throughout a manufacturing operation to improve quality.
Computer literacy.

Regular travel to supplier facilities required.  Travel up to 70%

Work From Home: Yes

Travel Percentage: 70%

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