Senior Quality Engineer — Remote-Ready Quality Leader

Röchling Medical; Rochester (MN); On-site; USD 100,000 - 140,000; Full time

Benefits offered by this job

Health management

Training & development

Food options

Flexibility

Job summary

Röchling Medical seeks a seasoned Quality Engineering leader to drive major quality system improvement projects and CAPA programs. You will coach cross-functional teams in document control, change control, training, and validation, while leading responses to major customer complaints and audits.

You will monitor quality performance, present metrics, and spearhead process improvements, including form and SOP revisions, change orders, and staff training to sustain regulatory compliance and product

Qualifications

• Bachelor's degree in engineering, Quality, Manufacturing, or related technical discipline.
• 8 years of Quality Engineering experience in a regulated manufacturing environment.
• ASQ CQE and Lean Six Sigma Black Belt certifications are preferred.

Responsibilities

• Lead major quality system improvement projects and CAPA SME.
• Coach and support quality processes: document control, change control, training, validation.
• Manage major customer complaints and audits as SME.
• Monitor quality performance and present metrics; drive improvements.
• Develop and revise forms, work instructions, and SOPs; manage related change orders.

Skills

Quality engineering

FDA/ISO knowledge

Problem solving

Leadership

Analytical skills

Communication

Risk assessment

Education

Bachelor's degree in engineering/related field

ASQ CQE certification

Lean Six Sigma Black Belt

Tools

Statistical software

Job description

Röchling Medical seeks a seasoned Quality Engineering leader to drive major quality system improvement projects and CAPA programs. You will coach cross-functional teams in document control, change control, training, and validation, while leading responses to major customer complaints and audits.

You will monitor quality performance, present metrics, and spearhead process improvements, including form and SOP revisions, change orders, and staff training to sustain regulatory compliance and product