Senior Process Engineer

Primary Responsibilities

• Plan and schedule program activities and resources (associates)
•  Process Control setup using data analysis method
•  Coordinating Special Process Validations
•  Participate in the execution of Quality functions in compliance with AS9001, ISO9001, ISO 13485, and international quality requirements and standards
• Cross-functionally assisting in preparation and updates of internal and SQA program documentation
• Support risk management activities related to manufacturing processes, such as pFMEA
• Review and assist in writing new procedures and work instructions or updating existing documents for customer programs
•  Evaluate and monitor manufacturing issues and product concerns, and help investigate non-conforming material to determine opportunities for improving manufacturing and product performance.
• Support coordination of Inspection programs, update procedures, forms, methods, and training
• Perform SQA and Client internal and external audits and assist in hosting external audits.
• Work with Clients to comprehensively understand and record requirements in a way that allows the development of an adequate Program Scope with execution that maximizes sales and margin for the SQA business model. In addition, project objectives and measures must be clearly defined to highlight successes and establish a baseline for follow-up business opportunities.
• Identify opportunities for the provision of additional services with existing clients.
• Conduct regular reviews with a cross-functional team to identify program trends and/or irregularities and bring them (and subsequent recommendations) to the attention of the Client  . Central to this review is the analysis of STEPQ data.  Analyze client programs' activity and provide meaningful feedback and direction. This may include a recommendation for the reduction of one kind of
  activity in one area (e.g., on-site audits of low-risk suppliers), or a recommendation for the increase of one kind of activity in another area (e.g., in-depth Assessments for critical suppliers) 
•  Identify opportunities for the provision of additional services (outside current business)

Qualifications, Skills and Experience

• Bachelor’s degree in engineering or related field from an accredited college or university. 
• 3+ years’ experience in Quality Engineering, Manufacturing Engineering, or Industrial Engineering 
• Experience working in an industrial manufacturing environment. 
• Proven experience in continuous improvement roles. 
• Excellent project management and organization skills
• Ability to work collaboratively with cross-functional teams. 
• Data-driven mindset with proficiency in data analysis tools such as 8D, SPC, PFMEA, and others. Lean Six Sigma Certified. 
• Proficient problem-solving skills with the ability to teach basic problem-solving techniques and facilitate problem-solving team events. 
• Strong engineering analysis skills
• Lead Auditor of Quality Management System experience. 
• Experience in implementation and maintenance of ISO 9001, AS9001, ISO 13485, and other international quality requirements and standards
• Experience managing change control processes. 
• Strong communication, presentation, and team building skills. 
• Manages time effectively, remains organized in all circumstances.
• Self-motivated with a high level of initiative.
• Must be able to travel to customer program sites and associate shadowing based on a planned schedule.