Stryker Staff Engineer, Supplier Quality Compliance in Limerick, Ireland
Requisition ID 21950BR
Job Title Staff Engineer, Supplier Quality Compliance
Group Global Quality and Ops
Division SGS Quality Assurance
Business Unit QA Global Supplier Quality
Business Function Quality Assurance
Employment Category Full Time
Percent Travel Required Up to 40%
Stryker is one of the world’s leading medical technology companies and together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. Stryker products and services are available in over 100 countries. 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.
Job Description / Information
Working in partnership with the Global Supplier Network, you'll be involved in the ongoing support for the internal business units to address ongoing supplier quality issues, development of suppliers and ensuring that our external supply chain are capable of meeting expectations from a quality, service and cost perspective.
You will serve as liaison between suppliers and Stryker to drive effective continuous improvement as a result of the supplier base. You willwork with internal customers and suppliers in support of supplier quality issues; provide technical support for activities related to supplier quality system assessment and performance evaluation.
You will 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 our product quality and regulatory requirements.
This role will provide coaching and guidance to the SQE team to ensure compliance to technical, regulatory and Stryker requirements. This person will also act as the Single Point of contact for communication of issues for the suppliers within their commodity alignment.
Key Areas of Responsibility
Identify and plan training to address gaps in both skills and behaviour. Form input to performance reviews.
Act as liaison for customer groups on key compliance issues
Act as Single Point of Contact for Strategic Suppliers in a Global function
Provides leadership to the SQE Team being responsible for the plant metric reporting and local SME for SQ procedures & processes
Ownership and reporting on all quality issues associated with suppliers within the assigned commodity. Ensure all Supplier related material quality issues are effectively communicated.
Oversight of the supplier material related processeswhich include: Material Review Board to ensureCoordination of MRB activities with the business unit to ensure the timely assessment of potential non conforming products.
Act as a point of Contact for supplier Quality during External Audits and Internal Audits as required.
Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.e. FDA, IMB, Notified bodies, etc)
Develop structured communication channels with strategic sourcing, identifying responsibility by commodity / supplier.
Liaisingwith the Manufacturing and Quality groups and Business Units, in assessing and addressing material quality issues.
Track supplier quality performance measurement (KPI’s) and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews and represent the SQE team at the Monthly Business Review.
Oversight of the Approved Supplier List (ASL) in conjunction with the Procurement function
Drive continuous improvement activities focusing on supplier quality.
Professional Requirements- Required:
Bachelor’s Degree in Engineering or Science fields
Minimum of 7 years’ experience in manufacturing environment.
Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
Working knowledgeof FMEA, Validation Programs and SPC processes in a highly regulated environment
Good knowledge of lean tools and concepts. Demonstrated the ability to apply lean concepts throughout a manufacturing operation to improve quality
Demonstrated working knowledge to influence positively the trend of the relevant supplier quality metrics.
Strong analytical and problem solving capabilities with the ability to draw insights from data quickly and to define executable actions
Ability to plan, organize and implement multiple concurrent tasks
Strong communication skills. Must demonstrate the ability to communicate up/down and across different levels of the organization.
Demonstrated ability to work in cross-functional team environments
Willing to travel in support of business needs to different geographical locations.
Professional Requirements- Desirable:
Preferred industries are aviation, aerospace, automotive and defense
A working knowledge of the Supplier NADCAP Accreditation would be desirable, with particular reference to Special Process (SP) Accreditation
A working knowledge of Airbus SQIP process or industry equivalent
Lead Quality Auditor Qualification either in AS 9100 or ISO13485,CFR820 or comparable industry standards and regulatory requirements
ASQ CQE/CQM/PE certification
Strong project management capabilities with the capacity to leverage and apply knowledge
Must be able to represent & guide the SQ teams
Must enjoy working in team environment and undertaking leadership tasks
Must demonstrate outstanding collaboration and communication skills.
Highly motivated and able to build close relationships internally and externally.
Demonstrated ability for conflict resolution and constructive competence
Must demonstrate multitasking skills as this individual will be responsible for multiple tasks at the same time.
The individual should enjoy working in a dynamic and results oriented team environment focusing on quality, compliance and customer satisfaction
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