Quality Engineer - ISO 13485 & Continuous Improvement

Adecco US, Inc.; Coon Rapids (MN); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Medical

Dental

Life Insurance

401K and PTO

Job summary

Adecco US, Inc. is seeking a Quality Engineer for our Coon Rapids, MN facility. You will develop new processes/products, validate equipment, support continuous improvement on the shop floor, manage customer complaints and CAPA/NCR activities, and collaborate with QA technicians and inspectors.

The role requires a Bachelor's in Manufacturing Engineering, 2+ years of experience (5+ for senior), GD&T, and ERP/audit experience. On-site, Monday–Friday, with benefits and salary $80k–$100k.

Qualifications

• Bachelor degree in Manufacturing Engineering or related field is required.
• Minimum two years relevant experience / five years for senior position.
• Blueprint reading is mandatory – GD&T level expected.
• Experience developing manufacturing quality plans.
• Experience conducting process capability, GR&R, PFMEA and SPC studies.
• Experience working on NCR / CAPA.
• Experience working in an ISO environment, preferably ISO 13485.
• Proficient PC skills in a Windows environment.
• Effective written and verbal communication skills.
• Strong interpersonal and teamwork skills.

Responsibilities

• Develop new processes/products and revise existing ones.
• Lead validation of new products and technology (IQ, OQ, PQ).
• Collaborate with customers and suppliers on new product processes.
• Compile and analyze statistical data; conduct PFMEA, GR&R, and SPC studies.
• Create and maintain quality system documentation and work instructions.
• Manage NCR, CAPA and customer complaints from creation to closure.
• Lead change requests (SCR) with customers and ensure compliance with standards.
• Assist production to achieve objectives and generate quality KPIs.
• Perform internal and external audits.
• Serve as backup for other QEs and participate in LEAP workshops.
• Contribute to employee training and other duties as assigned.

Skills

Quality engineering

Problem solving

Communication skills

Teamwork

Education

Bachelor's degree in Manufacturing Engineering or related field

Tools

ERP system

GD&T

Job description

Adecco US, Inc. is seeking a Quality Engineer for our Coon Rapids, MN facility. You will develop new processes/products, validate equipment, support continuous improvement on the shop floor, manage customer complaints and CAPA/NCR activities, and collaborate with QA technicians and inspectors.

The role requires a Bachelor's in Manufacturing Engineering, 2+ years of experience (5+ for senior), GD&T, and ERP/audit experience. On-site, Monday–Friday, with benefits and salary $80k–$100k.