Quality Engineer - ISO 13485, CAPA & Validation Lead

Precera Medical; Coon Rapids (MN); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) plan

Paid time off (PTO)

Job summary

Precera Medical is seeking a Quality Engineer to lead process/product development and validation on the shop floor, ensuring ISO 13485 and FDA compliance. You will manage NCR/CAPA, lead change requests with customers, and work with QA Technicians and QARs on quality improvements.

The role involves cross-functional collaboration, data-driven analysis, and audits to sustain high quality across processes and products in a medical device environment.

Qualifications

• Bachelor's degree in Manufacturing Engineering or related field.
• 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.
• Create and update project-specific quality plans, ensuring adherence to customer requirements.
• Lead validation of new products and technology (IQ, OQ, PQ).
• Collaborate with customers and suppliers on new product processes.
• Lead customer complaints and supplier SCAR management.
• Compile and analyze statistical data to assess process capabilities.
• Create and maintain quality system documentation, including quality plans and work instructions.
• Manage NCR, CAPA, and customer complaints from creation to closure.
• Lead changes in production, ensuring compliance with customer agreements and ISO standards.
• Generate quality KPIs for PSM2 and support audits.

Skills

GD&T

Process capability

GR&R

PFMEA

SPC

NCR/CAPA

ISO 13485

Quality plans

Cross-functional teamwork

Documentation

Education

Bachelor's degree in Manufacturing Engineering or related field

Tools

ERP system

Windows PC environment

Job description

Precera Medical is seeking a Quality Engineer to lead process/product development and validation on the shop floor, ensuring ISO 13485 and FDA compliance. You will manage NCR/CAPA, lead change requests with customers, and work with QA Technicians and QARs on quality improvements.

The role involves cross-functional collaboration, data-driven analysis, and audits to sustain high quality across processes and products in a medical device environment.