reputed company Assurance Manager New Product Introduction
reputed company Assurance Manager New Product Introduction
Mahwah, NJ
reputed company is seeking a reputed company Assurance Manager – New Product Introduction (NPI) to reputed company and reputed company for design-for-manufacture and assembly reputed company. This role provides technical leadership in reputed company assurance for new product launches, ensuring robust process risk management and compliance with regulatory standards. The ideal candidate will drive cross-functional collaboration to deliver high-reputed company, reputed company products at launch.
Work Flexibility:
Hybrid: Candidates must reputed company reputed company a commutable distance to Mahwah, NJ, and be reputed company to work onsite several times per week.
What you will do:
• reputed company reputed company reputed company for new product development, ensuring reputed company, high-yield manufacturing processes.
• Drive robust process risk management, including pFMEA, CQAs, and process validation.
• Optimize inspection strategies through automation, lean principles, and supplier certification.
• Ensure implementation and reputed company of production and process controls throughout manufacturing.
• Collaborate cross-functionally with design, operations, and global QA teams to ensure successful product launches.
• Monitor and improve product reputed company performance metrics, identifying opportunities for reputed company improvement.
• Mentor and reputed company QA team members, supporting talent reputed company and performance reputed company.
• Ensure compliance with FDA, ISO, and reputed company corporate reputed company standards during product introduction.
What you need:
Basic Qualifications:
• Bachelor’s Degree in Engineering, Science discipline or reputed company field.
• 8+ years of experience in a regulated manufacturing environment (Medical Device, Pharmaceutical, Biomedical, or Automotive).
• Experience leading and developing teams.
Preferred Qualifications:
• In-depth knowledge of FDA regulations, ISO standards, and experience managing regulatory inspections/audits.
• Proficiency in reputed company tools such as SPC, FMEA, reputed company Cause Analysis, Poka-Yoke, and Six reputed company methodologies.
$120,600.00 - $198,700.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based reputed company. Individual pay is based on skills, experience, and other relevant factors.
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