採用
Required Skills
Manufacturing
GMP
ISO 13485
PPAP
MSA
SPC
PFMEA
Validation
Communication
Work Flexibility: Hybrid
What you will do:
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Support the implementation of process improvements to Corporate/Site/Division Supplier Initiated Change Request procedures and process.
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Served as owner, execute, and maintain the electronic systems related to SICRs, and support data alignment (SICR Database & OnePLM SICR Library)
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Challenge suppliers SICRs forms for completeness and accuracy. Discuss corrections to the form to guarantee a smooth assignment and execution of the change.
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Own & Execute Supplier Initiated change request (SICR) submitted by Global Suppliers
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Review Submitted SICRs and challenge suppliers for missing information & required deliverables for approving the change
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Organize SCRB with Key Stakeholders and get Buy in for Type of change.
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Review and Approve deliverables submitted by suppliers and coordinate with supplier for any corrections.
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Execute ECR/ECNs and Promotion requests in OnePLM for Change Approval at Stryker end.
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Support communication tools to internal and external customers (suppliers/site/division)
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Monitor and Maintain SICR KPIs.
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Support Global SICR Initiatives
What you will need:
Required qualification:
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Honors Bachelor’s degree in Engineering or Science fields or equivalency.
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3+ years of experience in manufacturing environment or equivalent.
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Basic knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
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Good communication skills.
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Willing to travel in support of business needs to different geographical locations.
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Good knowledge of continuous improvement methodologies
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Hands on experience of PPAP ,MSA, SPC documentation creation, review and Approval from suppliers.
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Good Hands on experience of Validation activity – IQ,OQ & PQ
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Good Know how of Manufacturing processes like welding, Molding, Machining etc.
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Good Hands on experience of PFMEA & Control Plan
Preferred qualification:
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Must enjoy working in a team environment
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Must demonstrate good collaboration and communication skills.
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Highly motivated and able to build relationships internally and externally.
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Must demonstrate multitasking skills as this individual will be responsible for multiple tasks at the same time.
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The individual should enjoy working in a dynamic and results-oriented team environment focusing on quality, compliance and customer satisfaction
Travel Percentage: 10%
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About Stryker

Stryker
PublicStryker Corporation is an American multinational medical technologies corporation based in Kalamazoo, Michigan.
10,001+
Employees
Kalamazoo
Headquarters
Reviews
3.6
10 reviews
Work Life Balance
3.2
Compensation
3.8
Culture
3.4
Career
3.6
Management
2.8
65%
Recommend to a Friend
Pros
Great benefits and compensation packages
Good company culture and team environment
Learning opportunities and career growth
Cons
Management changes frequently and inconsistently
Work-life balance issues and overtime demands
Limited career advancement opportunities
Salary Ranges
2,009 data points
Senior/L5
Senior/L5 · Senior Portfolio Manager
1 reports
$173,157
total / year
Base
$150,571
Stock
-
Bonus
-
$173,157
$173,157
Interview Experience
4 interviews
Difficulty
3.5
/ 5
Duration
14-28 weeks
Offer Rate
50%
Experience
Positive 0%
Neutral 50%
Negative 50%
Interview Process
1
Application Review
2
Phone Screen
3
Online Assessment
4
Multiple Interview Rounds
5
Presentation/Case Study
6
Field Assessment
7
Offer
Common Questions
Behavioral/STAR
Medical Device Knowledge
Sales Scenarios
Culture Fit
Past Experience
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