- Lead change control activities as related to Client’s Unique Device Identification efforts in regards to changes process control documents.
- Facilitate change control activities regarding the direct part marking efforts for vended product including first article inspection and leading the efforts for supplier notification process for addition of GTIN for UDI-DPM project.
- Ensure high level of compliance to FDA QSR/cGMPs and ISO standards in all assigned areas.
- Participate in continuous process improvement activities as related to the direct part marking process.
- Participate on project teams with internal departments to support product and/or process design and development activities.
- Review and Approve IGS CA & ECRs for UDI-DPM.
- Take the lead on queries related to the First Article Inspection by demonstrating timely communication with all stake holders.
- Identify opportunities to support/assist other approval functions with their UDI deliverables or execute cross-functional team's tasks in order to meet the project deadlines.
- Initiate FAI documentation within one week of approval of the P&A form by all stake holders.
- Bachelors of Science Degree in Engineering (Mechanical, Industrial, Biomedical, Biomechanical preferred)
- 3+ years’ experience as an Operations/Quality Engineer in a regulated production/manufacturing environment. Prefer experience within a medical device or pharmaceutical industry.
- Demonstrated applied knowledge of FDA and international medical device regulations and validation activities a plus.
- Demonstrated ability to effectively work cross functionally with other departments including Quality and Product Development.
- Demonstrated computer skills using Microsoft Office applications (Word, Excel, PowerPoint, etc.)
- Knowledge of QMS systems, ERP system would be highly desired (Windchill and Oracle preferred).
- Demonstrated problem-solving and troubleshooting skills.
- Demonstrated interpersonal and communication skills.
- Demonstrated ability to exhibit a positive, energetic approach to teamwork, with a high degree of emphasis on accountability.
- Demonstrated ability to advocate product excellence and quality.
- Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines.
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