- Generate, prepare and issue complex data for assigned quality reports.
- Provide input in Customer Feedback failure investigations.
- Review change orders and deviations
- Ensure maintenance of validated state, and consideration for re-validation during various design and process changes.
- Ensure maintenance of product ID and traceability, including that of safety critical parts.
- Review and approve the criteria for WIP reworks and re-inspections.
- Drive improvements in process capability and quality of products.
- Provide support to process validation and other processes on the manufacturing floor, warehouse and facilities as required.
- Proactively identify potential problems and drive continuous improvement, utilizing the CAPA/SCAR and other processes.
- Establish and monitor use of risk assessment tools for project tracking and management.
- Assure project adherence to Design Controls to deliver robust, manufacturable products which meet the defined delivery timeline, design inputs and quality metrics to meet business unit goals.
- Identify and drive countermeasures in instances when deviations to the project plan occur.
- Effectively communicate and maintain visual tools for project tracking and management
- Effectively employ Danaher Business System (DBS) tools and concepts to maximize efficiency and quality.
- Works with team members to develop team goals and plans, resolve problems and achieve goals.
Knowledge and skills:
- Fast learner, and able to quickly become adept at using the Danaher Business System tool set
- Readily accepts responsibility and accountability for project success and key decisions
- Experience in the application of production and process controls including process validation, process control plans and statistical process control.
- Experience in risk management process (sFMEA, pFMEAs, dFMEAs etc.).
- Communication skills, both oral and written.
- Ability to work effectively in a team environment and build strong working relationships.
- Foster an environment that values diversity and inclusion.
- High degree of initiative and self-motivation.
- Strong analytical and problem-solving skills.
- Complete all assigned and required training satisfactorily and on time
- Bachelor’s degree in technical field desired with 2+ years of related work experience OR
- Master’s degree in technical field desired with 0-2 years of related work experience
- Experience in the medical device industry, knowledge of CFR 21 Part 820 (QSR), ISO 13485.
- Quality engineering certification from the American Society for Quality (ASQ), or other qualifying organizations. Examples may include but not limited to the CQE, CRE, CQA, etc