Quality Engineer I - Manufacturing (Medtech)

TL;DR

Quality Engineer I (Manufacturing/Medtech): Providing quality support for materials, products, and processes with an accent on root cause analysis, CAPA management, and test method validation. Focus on executing equipment qualifications, ensuring ISO 9001 compliance, and mitigating risks to production KPIs.

Location: Onsite in Allentown, Pennsylvania, United States

Salary: $85,300 - $95,300

Company

hirify.global is a global leader in infusion therapy and pain management, developing and manufacturing innovative medical products to enhance patient and clinician safety.

What you will do

• Establish and modify quality standards for products and processes to prevent defects in components or final products.
• Perform root cause analysis and investigations for nonconformances, CAPAs, and complaint trends.
• Serve as the Quality Assurance representative for material review board (MRB) meetings.
• Lead and execute equipment installation, qualification, and test method validation activities.
• Audit production processes, raw materials, and suppliers to ensure established quality standards are met.
• Collaborate with cross-functional teams, including product design and production, to identify and mitigate quality risks.

Requirements

• Bachelor's Degree.
• 2-4 years of related experience.
• Must be based in or able to work onsite in Allentown, Pennsylvania, USA.
• Full working knowledge of relevant business practices and quality theories in a professional field.
• Ability to perform physical tasks including sitting, talking, and occasionally lifting up to 20 pounds.

Nice to have

• Applicable industry or professional certifications.

Culture & Benefits

• Comprehensive healthcare package.
• 401(k) retirement plan.
• Tuition reimbursement.
• Culture based on the "Sharing Expertise" philosophy for continuous improvement of healthcare.