- Facilitate change control activities regarding the direct part marking efforts for in-house and vended products, including the maintenance of large Excel change control trackers, creating relationships and following up with all change management stakeholders to meet project timelines.
- Lead change control activites as related to company’s Unique Device Indentification efforts in regards to changes in inspection documents and detailed operation sheets.
- Bachelor’s of Science Degree in Engineering (Mechanical, Industrial, Biomedical, Biomechanical prefered)
- 3+ years experience as an Operations 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, Purchasing, and Product Development.
- Demonstrated computer skills using Microsoft Office applications, especially Excel, including Word, 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.
- Ensure high level of compliance to FDA QSR/cGMPs and ISO standards in all assigned areas.
- Participate in daily 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 ctivities.
- Update inspection plans and operation sheets as related to product drawing changes.
- Assist in development and execution of process and equipment validation/qualifications (IQ, OQ, PQ).
- Submit product and/or process change control documentation and specifications.
- Demonstrate results orientation, ability to multi-task, learn quickly, prioritize and accomplish work with limited supervision.
- Direct responsibility to escalate issues to management that can impact project performance.
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