NPI Quality Engineer: Risk, Validation & Process Lead

CPC - Colder Products Company; Roseville (MN); On-site; USD 110,000 - 150,000; Full time

Job summary

CPC - Colder Products Company in Roseville, MN is seeking a Risk Management SME to lead cross-functional efforts ensuring alignment of market needs, engineering specs and risks. You will drive measurement validation, DVT/testing strategies, and CAPA programs across design, manufacturing and supply chain.

The role requires 7+ years in quality/manufacturing with ISO 13485/9001 expertise, strong analytical skills and robust communication. Up to 10% travel may be involved to support objectives.

Qualifications

• Bachelor's Degree in Engineering required.
• 7+ years of experience in Quality, Manufacturing, or related field.
• Proficient 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.
• Proven ability to resolve issues and participate in process improvement activities.
• Ability to define problems, collect data, establish facts and draw conclusions.
• Superb written communication skills, with a keen eye for detail and focused on target audience.
• Ability to effectively present information in one‑on‑one and small group situations.
• This role may require less than 10% of travel, domestically.

Responsibilities

• Lead cross-functional meetings to ensure Market Needs, Engineering Spec and risk are aligned and mitigated.
• Provide feedback on new tests or test methods to resolve measurement discrepancies and ensure correlation in measurement method.
• Attend team meetings and provide Quality Engineering input for potential design, process, and project risks.
• Provide input to Design Engineering on new component technology and assist in component selection with quality and reliability analysis.
• Support Design/Service Transfer by providing input to design and manufacturing, Project Management and Supply Chain.
• Review and develop design control documentation for accuracy, completeness and user-friendly content.
• Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, & PQ).
• Collaborate cross-functionally as NPI Quality Engineer; a Core Team Member, on new product/service development teams.
• Provides Statistical recommendations for formal DVT and Characterization testing as well as for process and other informal testing.
• Collaborate with suppliers and applicable CPC functional teams in developing statistically valid, highly capable, repeatable, and reproducible test methods for formal DVT, Characterization and other informal testing.
• Develop validation plans and protocols to verify that components and supplier product meets requirements.
• Review and approve process verification/validation test plans, protocols, reports, inspection procedures and associated documentation.
• Provide data driven feedback on results to resolve measurement discrepancies and ensure correlation in measurement method between in-process and Receiving Inspection in compliance with CPC requirements.
• Ensure correlation in measurement method between in-process and Receiving Inspection in compliance with CPC requirements.
• Problem Solving and Root Cause Analysis SME; Lead cross-functional meetings to investigate design-related issues (DVT failures), Facilitate, and conduct root cause analysis, Facilitate implementation and effectiveness of corrective and preventive actions (CAPA).
• Ensure traceability between design inputs, outputs, and test results.
• Performs other job duties as assigned to meet business needs.

Skills

Quality Management

Risk Analysis

Root Cause Analysis

CAPA

Statistical Methods

Problem Solving

Education

Bachelor's Degree in Engineering

Job description

CPC - Colder Products Company in Roseville, MN is seeking a Risk Management SME to lead cross-functional efforts ensuring alignment of market needs, engineering specs and risks. You will drive measurement validation, DVT/testing strategies, and CAPA programs across design, manufacturing and supply chain.

The role requires 7+ years in quality/manufacturing with ISO 13485/9001 expertise, strong analytical skills and robust communication. Up to 10% travel may be involved to support objectives.