Quality Engineer

Job Description

HiFyve is hiring a Quality Engineer in the cosmetics industry in Minneapolis, MN!

Salary: $75k-$100k/yr

Shift: Day Shift

Location: Minneapolis, MN

NOTE: This role does not offer sponsorship

Job Duties and Responsibilities

Lead quality-related problem-solving and root cause analysis in manufacturing to prevent recurrences.

Manage and execute process validation, equipment qualification, and cleaning validation activities.

Support investigations of technical issues and establish procedures and CAPA to maintain product quality and regulatory compliance.

Represent the Quality department in cross-functional meetings to resolve key quality issues and strategize work plans.

Coordinate cross-functional teams to address Non-Conformance issues, aiming to reduce scrap and improve First Pass Yield.

Analyze production and testing quality data to identify root causes and evaluate effectiveness of corrective actions.

Collaborate with internal teams and customers to define and monitor key quality metrics.

Update and author SOPs; perform internal audits and support quality training efforts.

Ensure compliance with cGMP, FDA, ISO 9001, safety, and environmental standards.

Participate in safety, GMP, and other required company training sessions.

Education Requirements

Bachelors degree in Engineering (Masters degree preferred)

ASQ CQE is a plus

Knowledge, Skills and Abilities:

35 years of experience in cosmetics or pharmaceutical industries (medical device does not qualify, 12 years with Masters degree)

Strong knowledge of quality systems including ISO 9001, GMP, and FDA regulations

Experience with CAPA, FMEA, SPC, and quality management systems

Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint)

Excellent analytical, problem-solving, and critical thinking skills

Strong organizational and communication abilities

Ability to work independently in a fast-paced, cross-functional environment

Six Sigma Green or Black Belt certification preferred

ISO 9001 Lead Auditor Certification is a plus

Bilingual in English and Spanish is a plus

If you are interested, please apply.

Full-time