Senior Quality Engineer
About the Role:
This Senior Quality Engineer will lead new product development programs to production approval by working with customers and program management, ensuring robust processes and documentation are developed and a successful transfer to production. The person in this role needs to be onsite 5 days a week and will report to the Director of PMO.
Responsibilities:
* Work Cooperatively: Work collaboratively with all employees in a team environment to achieve quality goals.
* Serve as Quality Representative: Serve as the quality representative on cross-functional new product development teams to ensure that quality is integrated into every aspect of the project.
* Review Documents: Review all documents and specifications referenced on the drawing or purchase orders, identify concerns and communicate to the cross-functional new product development team. Drive drawing and specification changes needed to effectively transfer projects to production.
* Proactive Leadership: Proactively lead and anticipate the needs of the customer and/or project and develop plans to mitigate risks encountered during the project.
* Quality Assurance: Respond in a timely and professional manner to internal and external customer requests that pertain to quality, understand and follow regulatory requirements for FDA, ISO and Government standards.
* Validation Protocols: Develop and optimize validation protocols and execute reports to meet regulatory, customer and internal production requirements.
* Inspection Plans: Develop inspection plans, fixtures and methods to achieve quality requirements and standards, document quality issues identified during development and to ensure best practices are implemented.
* Risk Management: Investigate and determine root cause of product quality issues and defects for new products and implements solutions to resolve issues; assist other personnel, as required, with the Corrective Action process.
* Project Prioritization: Establish and execute priorities for multiple programs of varying complexity to achieve customer expectations based on new product development schedules established by the program management team.
* Continual Improvement: Drive continual improvement in regard to procedures, processes, work flow, compliance to standards, and to ensure product quality.
* Mentorship: Provide project knowledge and insight to Sustaining Engineers and support production issues as needed.
* Internal Audits: Responsible for performing internal audits, as required, based on internal audit schedule.
* Team Guidance: Mentor and provide guidance, in regard to quality and project related issues, to less experienced team members to drive personal and professional growth of the team, timely and appropriate resolution of issues.
* Innovation: Proactively identify gaps, and potential solutions to resolve them, in existing equipment, resources and technology to ensure the quality team is well-positioned to address ever-changing market and customer needs.
About the Benefits:
The salary range for this position is $80K - $120K Annually + bonus. This compensation package provides an opportunity for career growth and financial stability in a dynamic and challenging role.