Senior Quality Engineer


Posted 2 years ago in Healthcare

Sr. Quality Compliance Engineer


Job Summary:

Responsible for Headquarter ISO and FDA Internal Audit Program, Corrective and Preventative Actions Monitoring as well as Product Corrections and Removal Administration for Smith & Nephew’s Headquarter site. The position is responsible for compliance to the QSR including but not limited to FDA, Health Canada (HC), ISO, PAL and verifying that system requirements, such as complaints handling, deviations, CAPA, supplier management process, training, change controls are achieved through internal auditing. Take action to drive CAPA resolutions.

- Lead the internal audit functions to comply with ISO, FDA, HC, PAL and extern

Effectively communicates results of audit to management. Follow up on issues; ensures timely resolution and closure.

- Maintain current, complete and accurate data in the auditing database.

- Track and report on the Complaint Process Effectiveness and Corrective and Preventative Actions and make recommenations for improvements.

- Provides auditing metrics report to management during monthly management reviews. Participates on departmental cross functional team as requested such as Part II compliance.

Makes a positive contribution as demonstrated by: make suggestions for improvements, provides overtime as needed and create and update procedures as needed.

- Collaborates with other sites to ensure uniform implementation of Quality Systems Manual. Fulfills QSR as described within the Quality Manual. Benchmark other companies (SNN & external) to assess and implement best practices with the primary objectives of compliance excellence, process improvements and non-value added work through Lean Thinking.


- B.S. Engineering/Science required


Great company with multiple locations

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