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Gurugram, 122001, IN
Job details
Work flexibility: Hybrid
Req ID: R536328
Employee type: Full Time
Job category: Engineering
Travel: 10%
Relocation: No
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Why join Stryker?
Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
Job description
What you will do:
- Responsible for the development, revision, maintenance, and inactivation of the local Stryker site procedures ensuring the alignment with the corporate guidelines for purchasing controls.
- Collaborate with Procurement, Site Quality, Regulatory, and Regional Supplier Quality teams on strategic initiatives and sustaining activities to support successful supplier quality controls programs.
- Support tracking and reporting of KPI and other metrics associated with supplier performance. Articulate detailed supplier performance results and trends to appropriate levels of management.
- Support Third Party inspection (FDA, Notified Body etc.) and Stryker Corporate audits of the quality system.
- Execute supplier quality agreements (SQA) and Supplier Change Control Agreements (CCA)
- Provide best in class support to our business partners across Stryker for successful implementation of compliant and efficient Supplier Quality Controls programs.
- Support local initiatives and projects for improvement, and implementation of processes to build a best in-class Supplier Quality Controls organization.
- Work with site and divisional counterparts to own Corporate Purchasing Controls NC’s and CAPA’s (containment actions, root cause, corrective/preventive action, etc.).
- Additional duties, as assigned.
What you need:
Required:
- B.Tech (Electronics/Electrical/Mechanical) with 2-5 years of experience in Supplier quality.
- Knowledge of ISO 13485, FDA, EUMDR and regional medical device regulatory requirements.
- Ability to effectively communicate information to team members, leaders, management, and suppliers.
- Experience supporting third-party inspection (FDA, Notified Body etc.) within the medical device industry.
- Proficient in MS Office Suite (including Word, Excel, Power Point etc).
- Strong interpersonal skills to work with cross-functional teams (engineering, R&D, manufacturing, regulatory affairs).
Preferred:
- Understanding of Medical Device Regulatory Compliance (ISO 13485, CFR 820, or comparable standard / regulation) and EU's Medical Device Directive.
- Excellent communication and influencing skills, with the ability to manage multiple tasks and represent the Quality function across teams
- Preferred German Language exposure.
- ISO 13485 Lead Auditor certification or equivalent