Senior Quality Engineer: Risk & Validation Leader

Colder Products Company

Roseville (MN)

On-site

USD 105,000 - 120,000

Full time

5 days ago

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Benefits offered by this job

Healthcare

Dental & Vision

401k with company match

Profit sharing

Onsite gym

Paid time off

Referral bonuses

Job summary

Colder Products Company (CPC) is seeking an experienced Quality leader to drive risk management, CAPA, and design control activities across cross‑functional teams. You will ensure traceability from design inputs through validation, support supplier qualification, and advance CPC quality systems to meet ISO 13485 and ISO 9001 standards.

The role requires a Bachelor's in engineering, 10+ years in Quality/Manufacturing, and strong analytical/problem-solving skills, with occasional travel to support

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.
Willingness to travel domestically up to ~10%.

Responsibilities

Lead cross-functional risk management meetings to align market needs, engineering specs and risk; justify for leadership; drive design controls and documentation.
Lead root-cause analysis and CAPA, ensure traceability from design inputs to test results, and coordinate validation activities.

Skills

Analytical thinking

Education

Bachelor's degree in engineering

Job description

The role requires a Bachelor's in engineering, 10+ years in Quality/Manufacturing, and strong analytical/problem-solving skills, with occasional travel to support

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