Senior Quality Assurance Manager

3 hours ago

Lake Forest, California, United States Velosity Full time
Senior Quality Engineer

We are seeking a highly skilled Senior Quality Engineer to join our team at Velosity. As a key member of our quality team, you will be responsible for leading new product development programs to production approval by working closely with customers and program management.

Key Responsibilities:

  • Lead cross-functional new product development teams to ensure robust processes and documentation are developed and successfully transferred to production.
  • 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.
  • Proactively lead and anticipate the needs of the customer and/or project, and develop plans to mitigate risks encountered during the project.
  • 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.
  • Develop and optimize validation protocols and execute reports to meet regulatory, customer, and internal production requirements.
  • Develop inspection plans, fixtures, and methods to achieve quality requirements and standards, document quality issues identified during development, and ensure best practices are implemented.
  • Work closely with the metrology team to schedule and drive product first article inspections, capability studies, gage R&Rs, etc. Review data to ensure accuracy for submission to customers.
  • Investigate and determine root cause of product quality issues and defects for new products and implement solutions to resolve issues; assist other personnel, as required, with the Corrective Action process.
  • 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.
  • Drive continual improvement in regard to procedures, processes, work flow, compliance to standards, and to ensure product quality.
  • Provide project knowledge and insight to Sustaining Engineers and support production issues as needed.
  • Responsible for performing internal audits, as required, based on internal audit schedule.
  • 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.
  • 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.

Requirements:

  • Preferred Bachelor's degree in engineering or related field, or equivalent experience in a contract manufacturing environment, preferably in regulated industries.
  • Valid identification and the ability to work legally in the United States.
  • Preferred 8 years of experience in quality with minimum of 2 years in plastic injection molding.

Working Conditions:

Teamvantage is a non-smoking, climate-controlled, professional injection molding facility. The manufacturing environment may be subject to airborne contaminants and chemical odors as would be customary in an injection molding facility.

We are proud to be an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, veteran, marital, or disability status.

We maintain a drug-free workplace and perform pre-employment substance abuse testing. Velosity is an E-Verify employer. Velosity maintains ITAR-compliant operations in our facilities. Due to ITAR regulations, this role is only open to U.S. Citizens, lawful permanent residents (green card holders) or foreign nationals granted refugee or asylee status. Individuals with temporary visas (e.g. E, F-1, H-1, H-2, L, B, J, TN or OPT) are not eligible for hire in this role.

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