Sr Engineer I - External Supplier QA
• Perform capability assessment of suppliers within assigned commodity using incom-ing inspection or supplier process data to develop a reliable supply chain of quality components.
- Lead supplier approval and reassessment activities within assigned commodity including, but not limited, to supplier approval surveys, risk assessments, onsite audits, and quality agreements.
- Ensure supplier related quality issues (i.e. customer complaints, non-conformances) with assigned commodity are corrected to prevent recurrence. Involving partnering with the supplier on the use of root cause analysis tools paired with a formal corrective action process.
- Support purchase component approval process including engineering drawing and validation review and approvals.
- Execution of GxP Audits worldwide
- Ensures immediate action, including for cause visits, is taken with suppliers on issues deemed critical.
- Provides a high level of service to Alcon internal customers (Procurement, MS&T, R&D, and site level QA).
- Supports, manages and partners with suppliers on projects to meet business re-quirements such as capacity increases or cost saving initiatives.
- Ensures that appropriate Alcon and Novartis QS requirements are implemented at the suppliers within assigned commodity.
Posting Dates: 10/16/16 – 10/23/16
Work Schedule: 1st shift EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements Bachelor’s degree from an accredited institution in an Engineering, or Physical Science discipline or equivalent years of directly related experience.
- 3+ years’ experience in Quality Engineering within Medical Device/Healthcare/Pharmaceutical Industry with at least 2 years in a role involving supplier oversight.
- Quality System requirements (QSR), ISO standard requirements and applicable industry standards (AAMI standards, EN/ISO Standards). Knowledge of statistical techniques, equipment and process validations.
- GxP auditing experience in regulated industry
- Experience in auditing and developing and executing action plans
- Experience using root cause analysis tools
- Strong analytical and innovative skills.
- Strong communication skills and ability to work effectively with all organizational levels
- Strong project management skills and change management skills preferred
- Lean Six Sigma experience preferred
- Ability to travel domestically and internationally up to 40% of the time
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