Supplier Quality Engineer (Temporary Fixed Term Contract)
Collaborates with suppliers to assure the quality of their products, materials, components and/or operations. Monitors supplier performance and supports efforts to develop and implement changes to improve the production process. Follows up with suppliers on quality deviations and ensures that solutions are identified and implemented.
This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree, or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires attention to detail in making evaluative judgements based on the analysis of factual information. This job typically requires a degree or equivalent and a minimum of 2 or more years’ experience.
We are open to looking at this role being based across our Cork or Limerick sites and would consider someone being based remotely, providing they can attend one of our sites 2 days per week.
Your key responsibilities:
General Skills 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 is 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 will work 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.
Technical understanding of manufacturing prints and tolerancing
Knowledge in statistics
Strong communication skills
Strong problem-solving skills
Strong team player
Good understanding and ability to work with Microsoft Office
Basic understanding of manufacturing processes
Fluent in written & oral English
Mobility to international assignments
Willing to travel in support of business needs to different geographical locations
Basic understanding of project management
Demonstrated interpersonal skills
Ownership for supplier quality performance and measurement including KPI’s and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews
Lead quality issues with suppliers & partner with Internal Customers; Lead effective supplier containment and corrections/corrective actions
Act as point of contact for Internal/ External Customer groups on key compliance issues related to assigned suppliers
Participate in External Audits and Internal Audits as needed. Ensure Regulatory compliance in area of responsibility to GMP of all medical device’s regulatory agencies (i.e. FDA, IMB, Notified bodies, etc)
Responsible for accuracy and integrity of supplier data that ensures compliance with documented procedures & 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 the 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.
Liaising with the Manufacturing and Quality groups, in assessing and addressing material quality issues with assigned suppliers.
Maintenance of the Approved Supplier List (ASL) in conjunction with the Global Sourcing, Supplier Controls and Audit functions
Deliver continuous improvement activities focusing on supplier quality
Participate as required in SCRB in conjunction with key stakeholders
Support assessment of supplier changes
Participate in supplier audit program – planning, execution and closure
Participate in supplier reviews for assigned suppliers as required
Participate in cross functional projects both locally & globally as required
Partner with SQM functions and Strategic Sourcing on the developments and approval quality assurance agreements with suppliers.
What are we looking for?
Bachelor’s Degree in Engineering or Science fields
Minimum of 2 years’ experience in manufacturing environment or equivalent.
Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
Good knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment
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
Ability to plan, organize and implement multiple concurrent tasks
Strong communication/ influencing 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
Willing to travel in support of business needs to different geographical locations.
Good knowledge of continuous improvement methodologies
Must enjoy working in team environment
Must demonstrate strong collaboration and communication skills.
Highly motivated and able to build close relationships internally and externally.
Demonstrated ability to prioritize and deliver against timelines
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
Professional Requirements- Desirable:
Preferred industries are medical device, aviation, aerospace, automotive and defense
Internal Quality Auditor Qualification either in AS 9100 or ISO13485, CFR820 or comparable industry standards and regulatory requirements
Work From Home: Not available
Travel Percentage: Up to 25%