Senior Supplier Quality Engineer

Requisition ID 27590BR
Job Title Senior Supplier Quality Engineer
Group Global Quality and Ops
Division SGS Quality Assurance
Business Unit QA Global Supplier Quality
Business Function Quality Assurance
Country United States
State/Province IL
City Cary
Employment Category Full Time
Percent Travel Required Up to 20%
Shift 1st
About Stryker
Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other characteristic protected by applicable law. We are an EO employer ? M/F/Veteran/Disability.
Job Description / Information
Serve as a liaison between suppliers and Stryker to drive effective continuous improvement as a result of 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 meet our requirements and continually meet and adapt to product quality and regulatory requirements.
Serves as an active member of hub and spoke teams (led by GPOs) to establish, implement, and maintain Global Regulatory and Quality processes and documents supporting our Global QMS.
Leads hub and spoke teams to establish, implement, and maintain Global Regulatory and Quality processes and documents supporting our Global QMS.
Key areas of responsibility
+ Own supplier quality performance and measurement KPIs and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews.
+ Lead quality issues with suppliers and partner with internal customers.; Lead effective supplier containment and corrections/corrective actions.
+ Act as point of contact to internal/external customer groups on compliance issues related to assigned suppliers.
+ Engage in external and internal audits as needed. Ensure regulatory compliance in area of responsibility to GMP of all medical device regulatory agencies.
+ Responsible for accuracy and integrity of supplier data that ensures compliance with documented procedures and processes.
+ Ownership and reporting on all quality issues associated with the assigned suppliers. Ensure all assigned supplier-related material quality issues are effectively communicated to key stakeholders.
+ Participate in supplier material-related processes which include Material Review Board to ensure coordination of MRB activities with the business unit to ensure the timely assessment of potential non-conforming products.
+ Maintain structured communication channels with strategic sourcing, identifying responsibility by commodity/supplier.
+ Liaise with the Manufacturing and Quality groups, in assessing and addressing material quality issues with assigned suppliers.
+ Maintain the Approved Supplier List (ASL) in conjunction with the global sourcing, supplier controls, and audit functions.
+ Support the assessment of supplier changes.
+ Deliver continuous improvement activities focusing on supplier quality.
+ Participate as required in SCRB in conjunction with key stakeholders.
+ Support the assessment of supplier changes.
+ Participate in supplier audit planning, execution, and closure.
+ Participate in supplier reviews.
+ Participate in cross-functional projects.
+ Partner with SQM functions and strategic sourcing on the developments and approved quality assurance agreements with suppliers.
Minimum Qualifications
Education / work experience
+ BS in a science, engineering or related discipline.
+ Minimum of 3 years experience in manufacturing environment or equivalent preferred.
+ Internal Quality Auditor Qualification (ISO 13485, CFR 820 or comparable industry standard and regulatory requirements).
+ Prior divisional or site experience desired.
+ Prior cross-site/division experience desired.
Knowledge / competencies
+ Thorough knowledge and understanding of US and International Medical Device Regulations.
+ 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.
+ Basic knowledge of FMEA, validation programs and SPC processes in a highly regulatory environment desirable.
+ Basic understanding of manufacturing prints and tolerancing.
+ Basic 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.
+ Demonstrated ability to work in cross-functional team environments.
+ Basic understanding of manufacturing processes.
+ Ability to plan, organize, and implement multiple concurrent tasks.
+ Good knowledge of continuous improvement methodologies.
+ Computer literacy.
+ Some travel may be required.
All 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

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