Supplier Quality Engineer
Location :
Clifton NJ US 07013
Job Type :
Direct
Reference Code :
20935-BZ1
Compensation : 100000.00 - 140000.00 USD/YEAR
Start Date :
03/10/2022
Hours :
Full Time
Required Years of Experience :
4
Required Education :
BS Engineering
Travel :
No
Relocation :
No
Job Industry :
Medical Devices
Job Description :
- Permanent position for a Supplier Quality Engineer to support the Supplier Quality Manager in developing initiatives for continuous improvements to the Supplier Quality program.
- Supplier Quality program should be in compliance with applicable domestic & international requirements laws, and guidance.
- Work cross functionally with Operations, Engineering, Sourcing/Purchasing and Quality Assurance Organizations, to develop and implement Supplier Quality programs and procedures.
- Serve as Supplier Quality Lead / SME during internal audits and 3rd party inspections/audits (FDA, BSI, TUV).
- Oversee audits and assessments of current and potential new suppliers.
- Responsible for driving failure analysis and reports on effective corrective actions / supplier corrective action requests (SCARs), NCMR’s and supplier related CAPA’s.
- Manage supplier quality performance results and measurement KPIs.
- Enable reporting of metrics for monthly management meetings and management reviews.
- Initiate & support supplier development activities, establish & sustain effective partnerships with suppliers, resolve systemic supplier issues, and develop technical capability.
- Participate in the Part Qualification process.
- Negotiate and Finalize Quality Agreements such as Supplier Quality Agreement, Service Agreement, Intra-Company Quality Agreement, etc. for supply base spread globally.
- Oversee validations and qualifications of supplier facility to qualify manufacturing processes and overall quality of part/component manufacturing.
Required Qualifications :
- BS Engineering.
- Minimum 4 years experience in a medical device (capital goods with electromechanical components and/or disposables) manufacturing environment.
- Preferred Supplier Auditing Experience.
- Strong interpersonal and communication skills.
- Excellent quantitative and analytical skills.
- Ability to prioritize tasks in a fast-paced environment.
- Experience of administering Supplier Corrective Action Programs.
- Excellent working knowledge of MS Office (Word/Excel) and a statistical based software package (Minitab preferred).
- Knowledge of the principles and practices of process validation.
- A working knowledge of quality improvement tools and techniques.
- Strong influencing skills and the ability to build strong interpersonal relationships.
- Work related travel (Domestic and overseas) 10 – 20 %.
Contact: Bill Zukowsky
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