Senior Quality Engineer

CPC - Colder Products Company; Roseville (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

CPC - Colder Products Company is seeking a Risk Management SME to lead cross-functional reviews ensuring alignment of Market Needs, Engineering Specifications and risk justification for leadership approval. The role focuses on FMEA, measurement integrity, and traceability across design inputs and test results.

You will provide Quality Engineering input on design, process and project risks, support transfer activities, develop validation plans, and drive CAPA via root-cause analysis with

Qualifications

• Bachelor's Degree in Engineering is 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.
• Superior written communication skills with attention to detail.

Responsibilities

• Lead cross-functional meetings to ensure alignment of market needs, engineering specs and risk with leadership approval and identify process risks for internal and external parts and assemblies.
• Provide feedback on tests or test methods to resolve measurement discrepancies and ensure correlation in measurement methods between in-process, Receiving Inspection and Risk Management.
• Attend team meetings and provide Quality Engineering input for 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 with input to design and manufacturing, project management and supply chain to ensure manufacturability and testability.
• Review and develop design control documentation for accuracy 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 on new product/service development teams to ensure conformance with CPC QMS and lead deviation justification if necessary.
• Provide data driven feedback on results to resolve measurement discrepancies and ensure correlation in measurement methods.
• Develop validation plans and protocols to verify components and supplier product meets requirements; review and approve DVT test protocols.
• Review and approve process verification/validation test plans, protocols, reports, inspection procedures and related documentation.
• Collaborate with suppliers and CPC teams to develop statistically valid, repeatable test methods for DVT and characterization.

Skills

Risk Management

Quality Engineering

Root Cause Analysis

CAPA

Statistical Methods

Design for Quality

Communication Skills

Education

Bachelor's Degree in Engineering

Job description

• Risk Management SME: Lead cross-functional meetings to ensure Market Needs, Engineering Spec and risk are aligned and mitigated or properly justified for leadership approval and identify process risks for both internal and external manufactured parts and assemblies (e.g., FMEA (Failure Modes Effects Analysis).
• Provide feedback on new tests or test methods to resolve measurement discrepancies and ensure correlation in measurement method between in-process, Receiving Inspection and Risk Management in compliance with CPC requirements. For example, if a new test is required to mitigate a risk identified in Risk Management the NPI QE needs to be involved in the development and approval of that new test method.
• Attend team meetings and provides 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 including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that new and refurbished tools and associated processes result in products that can be adequately manufactured and tested
• Review and develop design control documentation for accuracy, completeness and user-friendly content that meets the needs of target audience in support of device history records and device master records.
• 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 to ensure conformance with CPC QMS and lead deviation justification if necessary.
• 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 DVT test protocols. Provide data driven feedback on results.
• 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.

Qualifications:

Basic Requirements:

• 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. Candidates should be comfortable with occasional travel as needed to support business objectives.