Senior Quality Engineer: Lead Risk & Process Validation

CPC; Roseville (MN); On-site; USD 105,000 - 120,000; Full time

Benefits offered by this job

Health insurance

401k

Paid time off

Bonus eligibility

Job summary

CPC (Colder Products Company) in Minnesota seeks a Senior Quality Engineer to lead risk management, design controls, and CAPA within a fast‑growing manufacturing environment. You will partner with design, process, and supply chain teams to ensure products meet CPC QMS requirements and regulatory standards.

The role requires a engineering degree, 10+ years in quality or manufacturing, and proven problem‑solving, data analysis, and communication skills. Travel is expected to be under 10%.

Qualifications

• Bachelor's Degree in Engineering required.
• 10+ 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 alignment of market needs, engineering spec and risk.
• Provide feedback on tests and measurement methods to resolve discrepancies.
• Attend team meetings and provide Quality Engineering input for risks.
• Support Design/Service Transfer with input to design, manufacturing, Project Management and Supply Chain.
• Develop validation plans and protocols to verify that components and supplier products meet requirements.
• Review and approve process verification/validation test plans, protocols, reports and inspection procedures.
• Provide data driven feedback to resolve measurement discrepancies and ensure correlation in methods.
• Lead deviation justification and CAPA implementation when needed.

Skills

Quality Systems

ISO Standards

Problem solving

Written communication

Data analysis

Education

Bachelor's Degree in Engineering

Job description

CPC (Colder Products Company) in Minnesota seeks a Senior Quality Engineer to lead risk management, design controls, and CAPA within a fast‑growing manufacturing environment. You will partner with design, process, and supply chain teams to ensure products meet CPC QMS requirements and regulatory standards.

The role requires a engineering degree, 10+ years in quality or manufacturing, and proven problem‑solving, data analysis, and communication skills. Travel is expected to be under 10%.