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发帖数: 388 | 1 Sr Operational Excellence Engineer, JOB ID 2022BR Responsibilities:
Reports to Sr Operational Excellence Manager within Manufacturing/Operations.
Must have solid understanding of QSR 820 FDA Regulations and ISO 13485
Requirements.
Must be passionate about prioritizing Patient Care.
Works closely with Manufacturing floor Engineers, Technicians and Managers.
Completes hands-on activities in areas of: Non-Conformance Resolutions,
Evaluation of Process Changes and Design Changes.
Collaborates cross-functionally with QA, Manufacturing, Lifecycle Change
Management (LCM) and extended R&D team.
Must be a great, collaborative team player with can-do-attitude.
Must have hands-on experience in supporting or leading Sustaining/Process
Improvements.
Generates or authors procedures, test plans, protocols, reports and sound
scientific rationale.
Must have prior experience handling Process Validation and ongoing Process
Controls.
Must have intermediate-level knowledge of Design Control elements and Risk
Management.
Supports Internal and External Audits.
Willing to learn and lead CAPAs under the direction of Manufacturing and/or
QA.
May need to occasionally work with extended Quality team members on product
complaints.
Must have the ability to balance Business Priorities with User Needs.
Presents periodic updates to Managers and peers on key action items.
Additional Certifications in Lean/Six Sigma or other Professional
Certifications a big plus.
Requirements:
Must have at least 5 years of work experience in Medical Device or Biotech
industry with focus on Manufacturing Process and Production Controls.
Intermediate Knowledge of Statistical Tools and Practical Applications –
Sample Size, Hypothesis Testing, Design of Experiments.
Proficient in Microsoft Word, Excel and PowerPoint.
Beginner to Intermediate Experience in Minitab or Jump or other Statistical
Software. |
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