Stryker

Staff Engineer, Quality

2 weeks agoCork, Ireland

Why engineering at Stryker?

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.

Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team

Position Summary

Working in partnership with the Global Supplier Network, you'll be involved in the ongoing support for the internal business units to address ongoing OEM/CM 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 OEM/CM's 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 OEM/CM's 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 OEM/CM team to ensure compliance to technical, regulatory and Stryker requirements.

Key Areas of Responsibility

  • Act as liaison for customer groups on key compliance issues
  • Provides leadership to the OEM/CM Team being responsible for the plant metric reporting and local SME for OEM/CM Quality procedures & processes
  • Ownership and reporting on all quality issues associated with OEM/CM suppliers within the assigned commodity. Ensure all Supplier related material quality issues are effectively communicated.
  • Oversight of the OEM/CM 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.
  • Act as a point of Contact for OEM/CM Quality during External Audits and Internal Audits as required.
  • Ensure Regulatory compliance in area of responsibility to GMP of all medical device's regulatory agencies (i.e. FDA, IMB, Notified bodies, etc)
  • Develop structured communication channels with strategic sourcing, identifying responsibility by OEM/CM.
  • Liaising with the Manufacturing and Quality groups and Business Units, in assessing and addressing material quality issues.
  • Track OEM/CM quality performance measurement (KPI's) and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews and represent the OEM/CM quality 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 OEM/CM quality.

Professional Requirements- Required:

  • Honors Bachelor's Degree in Engineering or Science fields or equivalency.
  • Minimum of 4 years' experience in manufacturing environment.
  • Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
  • Working knowledge of 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:

  • 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

Personal Competencies

  • Must be able to represent & guide the OEM/CM quality 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

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/

About Stryker

Stryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Client-provided location(s): Cork, Ireland
Job ID: Stryker_Combined-nZfJVuoDJkAO

Perks and Benefits

  • Health and Wellness
    • On-Site Gym
    • Wellness Program
    • HSA With Employer Contribution
    • FSA With Employer Contribution
    • Long-Term Disability
    • Short-Term Disability
    • Life Insurance
    • Vision Insurance
    • Dental Insurance
    • Health Insurance
    • Virtual Fitness Classes
    • Mental Health Benefits
    • HSA
    • FSA
  • Parental Benefits and Childcare
    • Adoption Assistance Program
    • Family Support Resources
    • Fertility Benefits
    • Onsite/nearby childcare
    • Paid Family Leave
  • Work Flexibility
    • Flexible Work Hours
    • Remote Work Opportunities
    • Work-From-Home Stipend
    • Home Office Stipend
    • Hybrid Work Opportunities
  • Office Life and Perks
    • Commuter Benefits Program
    • On-Site Cafeteria
    • Holiday Events
    • Company Outings
    • Some Meals Provided
    • Snacks
    • Happy Hours
    • Casual Dress
    • Employee Resource Groups (ERG)
  • Vacation and Time Off
    • Leave of Absence
    • Sabbatical
    • Personal/Sick Days
    • Paid Holidays
    • Paid Vacation
    • Volunteer Time Off
  • Financial and Retirement
    • Financial Counseling
    • Relocation Assistance
    • Performance Bonus
    • Stock Purchase Program
    • Company Equity
    • 401(K) With Company Matching
    • 401(K)
  • Professional Development
    • Leadership Training Program
    • Fellowship Program
    • Associate Training Program
    • Work Visa Sponsorship
    • Lunch and Learns
    • Access to Online Courses
    • Shadowing Opportunities
    • Mentor Program
    • Promote From Within
    • Learning and Development Stipend
    • Tuition Reimbursement
  • Diversity and Inclusion
    • Diversity, Equity, and Inclusion Program

Company Videos

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