Senior Quality Engineer

Responsibilities

• Lead cross-functional meetings for risk management, including FMEA to align market needs and engineering specifications
• Provide feedback on new test methods to ensure measurement correlation between in-process and receiving inspection
• Support design and service transfers by providing input on material specifications, drawings, and inspection procedures
• Review and develop design control documentation for accuracy and compliance with device history and master records
• Assist in the development and approval of process and equipment validation/qualifications (IQ, OQ, and PQ)
• Collaborate as a core team member on new product development to ensure conformance with QMS
• Provide statistical recommendations for DVT, characterization, and process testing
• Lead root cause analysis and facilitate implementation of corrective and preventive actions (CAPA)

Requirements

• Bachelor's Degree in Engineering
• 7+ years of experience in Quality, Manufacturing, or a related field
• Proficiency with Quality System Regulations and ISO Quality System Standards
• Strong understanding of ISO 13485 and ISO 9001
• Excellent analytical decision-making and problem-solving skills
• Strong written and verbal communication skills
• Ability to travel domestically up to 10%

About the Company

CPC (Colder Products Company) engineers cutting-edge fluid connection technologies for industries including biopharmaceutical, thermal management, medical, industrial, and chemical handling markets.