Supplier Validation Engineer in Belfast at Stryker Corporation

Date Posted: 6/6/2019

Job Snapshot

Job Description

Supplier Validation Engineer (Temporary Fixed Term Contract)

Summary:

Collaborates with suppliers to that validation of suppliers’ processes are conducted in accordance with HeartSine requirements.  Monitors supplier validation activities and supports efforts to develop and implement changes to improve the production process and validate any changes. Follows up with suppliers on validation deviations or failures 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.

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 validation activities, development of suppliers’ validation processes and ensuring that our external supply chain is capable of meeting expectations relating to product and process validation. You will serve as liaison between suppliers and Stryker to drive effective validation processes within the supplier base. You will work with internal customers and suppliers in support of supplier validation activities; provide technical support for activities related to supplier validation activities.  This role will provide coaching and guidance to suppliers to ensure compliance with HeartSine validation requirements.

This person will also act as the Single Point of contact for communication with suppliers with respect to validation activities:

  • Good understanding of validation and risk management techniques and processes
  • Ability to understand manufacturing processes and assess validation requirements and potential process risks
  • Knowledge in statistics and sampling plans
  • Strong communication skills
  • Strong problem-solving skills
  • Strong team player
  • Good understanding and ability to work with Microsoft Office
  • 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
  • Responsible for accuracy and integrity of supplier validation data that ensures compliance with documented procedures & processes
  • Ownership and reporting on all validation activities associated with the assigned suppliers. Ensure all assigned supplier related validation activities are effectively communicated to key stakeholders
  • Liaising with the Manufacturing and Quality groups, in assessing and addressing validation requirements for assigned 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 validation 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.
  • 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

Work From Home: Yes

Travel Percentage: Up to 25%

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